SMR Shoulder Glenosphere (REF 1376.09.031)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390087834), received between Dec 7, 2023 and Jan 29, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K163397); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Osseointegration Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO REMOVE SEVERE HETEROTOPIC OSSIFICATION. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS PRODUCT INFORMATION OF ORIGINAL IMPLANT. PRE-EXISTING REVERSE COMPONENTS WERE REMOVED, INCLUDING ECCENTRICAL GLENOSPHERE DIA 36MM (PART NUMBER 1376.09.031) AND ASSEMBLY WITH NEW ECCENTRICAL GLENOSPHERE DIA 36MM (PART NUMBER 1376.09.031), CONNECTOR (PART NUMBER 1374.15.305), EXTENSION FOR HUMERAL REVERSE BODY (PART NUMBER 1352.15.001) AND REVERSE LINER STANDARD (PART NUMBER 1360.50.810) WAS IMPLANTED. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1964. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Impingement

  MAUDE report 24210892 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO COMPONENT LOOSENING. THE DATE OF THE PREVIOUS SURGERY IS UNKNOWN. THE FOLLOWING COMPONENTS WERE REMOVED: SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 2315575, STERILIZATION (B)(4). SMR REVERSE LINER STANDARD (PART CODE 1360.50.810, LOT NUMBER 23AT1TB, STERILIZATION (B)(4). SMR ECCENT. GLENOSPHERE Ø 36MM (PART CODE 1376.09.031, LOT NUMBER 2317656, STERILIZATION (B)(4). THE REVERSE HUMERAL BODY AND THE REVERSE LINER WERE REPLACED BY NEW COMPONENTS, WHILE THE GLENOSPHERE WAS REPLACED BY A COMPONENT FROM A DIFFERENT MANUFACTURER. DURING THIS REVISION, THE WHOLE SYSTEM IMPLANTED ON THE GLENOID SIDE BELONGS TO A DIFFERENT MANUFACTURER. THE NEXT SURGERY WAS PERFORMED ON (B)(6) 2025. THIS NEXT REVISION WAS REPORTED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2025-00022. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1965. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 23298436 ↗
• InjuryOct 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2024, DUE TO PAIN. ACCORDING TO THE RECEIVED INFORMATION, IT WAS THOUGHT THAT THE GLENOID COMPONENT WAS LOOSE ON THE CT SCAN, BUT DURING THE SURGERY IT WAS ACTUALLY FOUND TO BE WELL FIXED. A POSSIBLE LOW-GRADE INFECTION WAS HYPOTHESIZED, BUT NOT CONFIRMED. THE SURGEON PERFORMED DEBRIDEMENT AND WASHOUT, AND THE FOLLOWING DEVICES WERE EXPLANTED: · SMR REVERSE LINER + 6 MM (PRODUCT CODE 1360.50.020, LOT #19AT31L - STER. 2000052) - PRODUCT NOT SOLD IN THE US. · SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2009530 - STER. 2000208). · SMR ECCENTRIC GLENOSPHERE Ø 36MM (PRODUCT CODE 1376.09.031, LOT #2125951 - STER. 2200013). · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2214773 - STER. 2200189). · BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #2125165 - STER. 2100361). THE OTHER IMPLANTS REMAINED IN SITU. THE CUSTOMIZED GLENOID CMD 23-1509 WAS REQUESTED FOR THE CASE BUT AT THE END IT WAS NOT IMPLANTED. NEW DEVICES OF THE SAME SIZES WERE IMPLANTED. PATIENT IS A FEMALE, 73 YEARS OLD. NO CLINICAL DETAILS ARE AVAILABLE, IT WAS JUST REPORTED SHE HAS A HIGH BMI. PREVIOUS SURGERY TOOK PLACE ON

  Patient problems: Implant Pain

  MAUDE report 20448964 ↗
• InjuryDec 7, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  REVISION SURGERY PERFORMED ON 11TH OCTOBER 2023 DUE TO PAIN AND NICKEL-METAL ALLERGY. THE PATIENT'S SHOULDER PROSTHESIS HAS BEEN REVISED WITH THE COMPASSIONATE USE DEVICE CMD 23-1224. THE COMPONENTS INVOLVED IN THE REVISION SURGERY WERE THE FOLLOWING: - SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.15.010, LOT 2214887, STERILIZATION NUMBER 2200196) - SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.810, LOT 20AT4UX, STERILIZATION NUMBER 2100137) - SMR ECCENT. GLENOSPHERE Ø 36MM (PRODUCT CODE 1376.09.031, LOT 2217722, STERILIZATION NUMBER 2200224) - TT HYBRID REVERSE BASEPLATE #S (PRODUCT CODE 1379.15.160, LOT 2209111, STERILIZATION NUMBER 2200136) THE PREVIOUS SURGERY WAS PERFORMED ON DECEMBER 5TH 2022. EVENT HAPPENED IN UNITED STATES.

  Patient problems: Hypersensitivity/Allergic reaction; Implant Pain

  MAUDE report 18283678 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163397. One submission often covers many models, so check the product and lot details in each record.

• Z-1317-2023 · Feb 21, 2023 · Open, Classified
  SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210