SMR Shoulder Liner (REF 1377.50.010)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08033390002608), received between Dec 22, 2020 and May 18, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO INFECTION. DURING THE REVISION ALL PRE-EXISTING COMPONENTS HAS BEEN EXPLANTED: SMR CEMENTLESS FINNED STEM (PN 1304.15.200, LOT. 2102987, STER. 2100108); SMR HUMERAL HEAD D.48 H.16MM (PN 1321.09.481, LOT. 2101790, STER. 2100079); SMR ECC.ADAPTOR TAPER STANDARD (PN 1330.15.274, LOT. 2115996, STER. 2100280); SMR FINNED HUMERAL BODY (PN 1350.15.110, LOT. 2114697, STER. 2100274); SMR METAL-BACK GLENOID STD (PN 1375.21.010, LOT. 2100627, STER. 2100093); LINER F.MET.BACK GLEN.STANDARD (PN 1377.50.010, LOT. 21AT1AA, STER. 2100306); BONE SCREW Ø6,5 H.30MM (PN 8420.15.030, LOT. 2120657, STER. 2100314); BONE SCREW Ø6,5 H.30MM (PN 8420.15.030, LOT. 2121636, STER. 2100334). AND FOLLOWING NEW COMPONENTS HAVE BEEN IMPLANTED: FINNED STEM DIA. 21MM L.80MM (PN 1304.15.210); FINNED HUMERAL BODY MEDIUM (PN 1350.15.110); ECCENTRICAL 4MM ADAPTOR TAPER (PN 1330.15.274); HUMERAL HEAD DIA. 50 H. 21MM (PN 1324 .09.501). SURGERY HAS BEEN COMPLETED AS INTENDED. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2021. PATIENT IS FEMALE, DATE OF BIRTH: (B)(6)1953. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 25200761 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO FAILED ROTATOR CUFF. THE IMPLANT WAS CONVERTED FROM ANATOMIC TO REVERSE. THE FOLLOWING COMPONENT WAS REMOVED: LINER F. MET. BACK GLEN.STANDARD (PART CODE: 1377.50.010, LOT NUMBER: 19AT132, STERILIZATION: 1900326). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 22517822 ↗
• InjuryMay 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO INFECTION. INFECTION INDICATED REMOVAL OF ALL THE FOLLOWING IMPLANTS: - SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.220, LOT NUMBER 1606114, STERILIZATION UNKNOWN). - SMR FINNED HUMERAL BODY (PART CODE 1350.15.110, LOT NUMBER 1518947, STERILIZATION UNKNOWN). - SMR METAL-BACK GLENOID STD (PART CODE 1375.21.010, LOT NUMBER 1707510, STERILIZATION UNKNOWN). - LINER F.MET.BACK GLEN.STANDARD (PART CODE 1377.50.010, LOT NUMBER 14L0897, STERILIZATION (B)(4)). SUCCESSFUL REMOVAL OCCURRED. DATE OF PREVIOUS SURGERY UNKNOWN. THE PATIENT IS A MALE. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 22078131 ↗
• InjuryNov 24, 2021Break; Device Dislodged or Dislocated; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  SHOULDER REVISION SURGERY DUE TO BREAKAGE AND DISSOCIATION OF THE LINER (LINER F.MET.BACK GLEN. STANDARD CODE 137750010 LOT 16AT14B STER. 1600332) FROM THE CUSTOM-MADE METAL BACK GLENOID (CMD 18-1338 GLENOID IMPLANT 961714757 LOT 1903772 STER. 1900089). THE HUMERAL COMPONENTS WERE FROM A DIFFERENT MANUFACTURER. ACCORDING TO THE INFORMATION RECEIVED, INFECTION WAS PRESENT. IT WAS REPORTED THAT, DUE TO LINER DISSOCIATION, THE SCREW HEADS HAD WORN, CAUSING THE IMPOSSIBILITY TO REMOVE THE GLENOID IMPLANT AS IT WAS VERY SECURELY FIXED TO THE BONE. THE SURGEON PUT A CEMENT BALL IN BETWEEN THE JOINT AND LEFT IT. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021, THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2020. SURGERY ON 9TH NOVEMBER 2020 WAS A REVISION SURGERY DUE TO A SIMILAR ISSUE AND WAS REPORTED TO FDA (3008021110-2020-00119). THE INITIAL SURGERY WAS ON (B)(6) 2019. EVENT OCCURRED IN (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 12868966 ↗
• InjuryDec 22, 2020Break; Appropriate Device Problem Term/Code Not Available

  SHOULDER REVISION SURGERY DUE TO BREAKAGE AND DISASSEMBLY OF THE LINER (CODE 1377.50.010, LOT 17AT01A) FROM THE CUSTOM-MADE METAL BACK GLENOID (PRODUCT CODE 9617.14.757, LOT 1903772, STER. (B)(4)). IT WAS REPORTED THAT THE IMPLANT WAS USED IN COMBINATION WITH A HUMERAL SIDE FORM A DIFFERENT MANUFACTURER. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019, THE REVISION SURGERY ON (B)(6) 2020. DURING THE REVISION SURGERY ONLY THE LINER WAS REPLACED. ACCORDING TO FURTHER INFORMATION RECEIVED, THE PATIENT UNDERWENT A FURTHER REVISION SURGERY ON (B)(6) 2021 DUE TO SIMILAR REASONS (LINER DISSOCIATION AND BREAKAGE). THIS SECOND CASE WAS RECORDED UNDER COMPLAINT REFERENCE (B)(4) AND REPORTED TO FDA (REF. 3008021110-2021-00092). PATIENT IS 70 YEARS OLD. EVENT OCCURRED IN THE UK.

  Patient problems: Insufficient Information

  MAUDE report 11054684 ↗