DEPLOYDatabase

Incident · Injury

Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)

An FDA MAUDE injury report describes a Stryker Mako patient with persistent instability and pain requiring revision, attributed to mechanical loosening and bone over-resection. Source: FDA MAUDE MDR key 19203776, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.

Occurred 2020-11-11 · Stryker · Investigated by FDA

How to read this record

Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)

Machine-readable surfaces

Sources (3)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
  2. https://www.stryker.com/
  3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=21274950&pc=OLO

Common questions

What happened in Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)?
An FDA MAUDE injury report describes a Stryker Mako patient with persistent instability and pain requiring revision, attributed to mechanical loosening and bone over-resection. Source: FDA MAUDE MDR key 19203776, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on November 11, 2020 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)?
The incident is recorded as involving Stryker on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 3 sources (2 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

2
primary-fda-database
FDA database
1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE).

Deploy Watch

Track this incident.

We notify you when the regulator updates the record, the remedy status changes, or a related incident surfaces.

Canonical ID 58535151-42f7-4869-84cb-74fe833cec72