MSS - Humeral reverse liners 04.01.0450Recalls & reported problems
Medacta International SA · Hum. rev. constrained HCPE liner Ø39/+6 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630542750441), received between Jun 9, 2026 and Jun 9, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Device Dislodged or Dislocated
ON (B)(6) 2025, A PRIMARY REVERSE SHOULDER ARTHROPLASTY WAS PERFORMED FOR A FRACTURE THAT HAD NOT HEALED (FAILURE OF FIXATION). ON (B)(6) 2026 THERE WAS A TRAUMA RELATED DISLOCATION ON (B)(6) 2026, A FIRST REVISION SURGERY WAS PERFORMED DUE TO RECURRENT INSTABILITY/DISLOCATIONS. THE SURGEON REVISED THE LINER AND UPSIZED THE GLENOSPHERE FROM 36 MM TO 39 MM, AND CHANGED THE METAPHYSIS TO A REVERSE METAPHYSIS +9 MM/+20°. ON (B)(6) 2026 THERE WAS ANOTHER TRAUMA RELATED DISLOCATION ON (B)(6) 2026, A REDUCTION WAS PERFORMED UNDER ANESTHESIA FOLLOWING ADDITIONAL DISLOCATIONS, ON (B)(6) 2026, A SECOND REVISION SURGERY WAS PERFORMED DUE TO PERSISTENT INSTABILITY. THE SURGEON REVISED THE LINER TO A CONSTRAINED HCPE LINER D 39/+6 AND THE METAPHYSIS TO A HUMERAL REVERSE METAPHYSIS +9 MM/0°. ON (B)(6) 2026, THE SURGEON REPORTED THAT THE PATIENT HAD DISLOCATED AGAIN. CONCERNS WERE RAISED REGARDING POSSIBLE NEUROLOGICAL IMPAIRMENT RELATED TO THE PATIENT`S PREVIOUS BRACHIAL PLEXUS INJURY, POTENTIALLY CAUSING ISSUES WITH FUNCTION, MUSCLE TONE, AND STRENGTH. THEY WILL NOT PROCEED WITH A REVISION FOR THE MOMENT AND WILL MONITOR THE PATIENT DUE TO HER SEVERE NEUROLOGICAL CONDITION. THEY ARE AL
Patient problems: Joint Dislocation
MAUDE report 25442520 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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