SMR Shoulder 1360.54.821Recalls & reported problems
Limacorporate SPA · SMR Shoulder - Retentive Reverse Liner +6 mm Dia. 36 mm · Class 2 · Implant
All models of SMR Shoulder (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390268226), received between Jul 2, 2026 and Jul 2, 2026 — classified as 1 injury.
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.
InjuryJul 2, 2026Device Dislodged or Dislocated
REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO SHOULDER DISLOCATION. COMPLETE PATIENT'S CLINICAL HISTORY IS DESCRIBED BELOW. THE PATIENT HAD A FRACTURE OF THE PROXIMAL HUMERUS THAT WAS INITIALLY TREATED WITH AN OPEN REDUCTION AND INTERNAL FIXATION (SURGICAL PROCEDURE TO REPAIR SEVERE BONE FRACTURES USING HARDWARES LIKE SCREWS, PLATES AND/OR RODS). AFTER A FAILURE OF THE ORIF, ON (B)(6) 2026, THE SURGEON OPTED TO PERFORM A REVERSE ARTHROPLASTY USING A COMBINATION OF ALTIVATE REVERSE GLENOID COMPONENTS (FROM OTHER MANUFACTURER) AND SMR SYSTEM ON THE HUMERAL SIDE, CONSISTING OF: REVISION STEM CEMENTED DIA. 13MM H. 210MM (PN 1309.15.138); 140° FINNED REVERSE HUMERAL BODY (PN 1352.15.051); REVERSE LINER DIA. 36MM +6MM (PN 1360.54.820). DURING HEALING PROCESS PATIENT EXPERIENCED SOME SHOULDER INSTABILITY. THEREFORE, A REVISION SURGERY (REPORTED THROUGH MFR 3008021110-2026-00149) OCCURRED ON (B)(6) 2026, WHEN SURGEON REMOVED THE PRE-EXISTING LINER AND REPLACED IT WITH AN EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001) AND A RETENTIVE LINER REVERSE DIA36MM +6MM (PN 1360.54.821) TO INCREASE TISSUE TENSION. ALSO, THE GLENOSPHERE FROM OTHER MANUFACTURER WAS REPLACED WITH NEW ONE. AT THE
Patient problems: Joint Dislocation
MAUDE report 25687435 ↗
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 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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