SMR Shoulder Reverse Humeral BodyRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08033390002073), received between Feb 25, 2025 and Jun 16, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K110598); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryJun 16, 2026Unstable

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER INSTABILITY. PATIENT UNDERWENT PRIMARY SURGERY FOR REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2023 WITH THE FOLLOWING ASSEMBLY: FINNED STEM SHORT DIA 19MM (PN 1304.15.019, LOT 2302711, STERILIZATION 2300070). REVERSE HUMERAL BODY (PN 1352.15.010, LOT 2305346, STERILIZATION 2300099). REVERSE LINER STD DIA40 (PN 1365.50.810, LOT 22AT2GY, STERILIZATION 2300054) GLENOID PEG TT SMALL-R #MEDIUM (PN 1375.14.652, LOT 2300712, STERILIZATION 2300050). TT AUGMENTED BASEPLATE 7° S-R DIA27MM (PN 1375.15.507, LOT 2303113, STERILIZATION 2300060). CONNECTOR SMALL-R (PN 1374.15.305, LOT 2308047, STERILIZATION 2300105). GLENOSPHERE DIA40 (PN 1374.09.121, LOT 2305626, STERILIZATION 2300088). AFTER AROUND ONE YEAR THE CONSTRUCT BECAME UNSTABLE AND THE SURGEON REVISED THE PATIENT (MFR 3008021110-2026-00261) REMOVING THE ABOVE MENTIONED CONNECTOR, GLENOSPHERE AND LINER TO IMPLANT A MORE LATERALIZED ASSEMBLY CONSISTING OF: LATERALIZED CONNECTOR +2MM SMALL-R (PN 1374.15.312, LOT 2011107, STERILIZATION 2000241). GLENOSPHERE DIA36MM (PN 1374.09.111, LOT 2407091, STERILIZATION 2400065). REVERSE LINER DIA36 +3MM (PN 1360.50.815, LOT 23AT253, STE

  Patient problems: Joint Laxity

  MAUDE report 25519180 ↗
• InjuryJan 9, 2026Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO INFECTION AND SCAPULAR NOTCHING. PREVIOUS SURGERY OCCURRED ABOUT 9-10 YEARS BEFORE, AND ORIGINAL PROSTHETIC ASSEMBLY CONSISTED OF BASEPLATE, LATERALIZED CONNECTOR +4MM, GLENOSPHERE ECCENTRIC DIA 40MM AND SMR HUMERAL BODY REVERSE (PART NUMBER 1352.15.010, LOT UNKNOWN). DURING REVISION SURGERY THE ABOVE-MENTIONED REVERSE HUMERAL BODY WAS REPLACED WITH A NEW ONE. SURGERY WAS COMPLETED AS INTENDED. THE PATIENT IS MALE, DATE OF BIRTH (B)(6)1962. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 24018219 ↗
• InjuryApr 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO INFECTION. ALL THE FOLLOWING COMPONENTS WERE REMOVED: SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.140, LOT NUMBER 2211467, STERILIZATION (B)(4), SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 2012985, STERILIZATION (B)(4), SMR REVERSE LINER +3MM D.40MM (PART CODE 1365.50.815, LOT NUMBER 23AT023, STERILIZATION (B)(4), SMR GLENOSPHERE Ø 40MM (PART CODE 1374.09.121, LOT NUMBER 2321556, STERILIZATION (B)(4), SMR SMALL/STD CONNECTOR +2 (PART CODE 1374.15.322, LOT NUMBER 2213447, STERILIZATION (B)(4), SMR GLENOID PEG TT S/STD #M (PART CODE 1375.14.662, LOT NUMBER 1908192, STERILIZATION (B)(4), SMR GLENOID BASEPLATE STANDARD (PART CODE 1375.15.610, LOT NUMBER 1908455, STERILIZATION (B)(4), BONE SCREW Ø6,5 H.30MM (PART CODE 8420.15.030, LOT NUMBER 2327434, STERILIZATION (B)(4), BONE SCREW Ø6,5 H.35MM (PART CODE 8420.15.040, LOT NUMBER 2302588, STERILIZATION (B)(4). THE DEVICES REMOVED WERE REPLACED BY DIFFERENT COMPONENTS. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. THE PATIENT IS A FEMALE, DATE OF BIRTH FEBRUARY (B)(6) 1961. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 21770685 ↗
• InjuryMar 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO INFECTION. THE FOLLOWING REVERSE COMPONENTS PREVIOUSLY IMPLANTED WAS REMOVED AND REPLACED BY CTA HEMI-ARTHROPLASTY: SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 1600868, STERILIZATION (B)(4). SMR REVERSE LINER +6 MM (PART CODE 1360.50.820, LOT NUMBER 15AT1SQ, STERILIZATION (B)(4). SMR GLENOID PEG TT SMALL-R #M (PART CODE 1375.14.652, LOT NUMBER 1518555, STERILIZATION (B)(4). SMR GLENOID BASEPLATE SMALL-R (PART CODE 1375.15.605, LOT NUMBER 1517810, STERILIZATION (B)(4). SMR GLENOSPHERE Ø36MM SMALL-R (PART CODE 1376.09.025, LOT NUMBER 1604615, STERILIZATION (B)(4). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2016. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1947. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 21661889 ↗
• InjuryFeb 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY DUE TO SEPTIC LOOSENING PERFORMED ON (B)(6) 2025. PATIENT HAD A HYBRID IMPLANT CONSISTING OF THE FOLLOWING COMPONENTS (ALL REMOVED BECAUSE OF LOOSENING) AND THIRD-PARTY COMPONENTS: SMR CEMENTL. REV. STEM Ø13 MM (PART CODE 1308.15.134, LOT NUMBER 1816629, STERILIZATION (B)(4). SMR HUMERAL EXTENSION + 9 MM (PART CODE 1352.15.001, LOT NUMBER 1918660, STERILIZATION (B)(4). SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 1919690, STERILIZATION (B)(4) SMR REVERSE LINER STD D.40MM (PART CODE 1365.50.810, LOT NUMBER 19AT18L, STERILIZATION (B)(4). THE BASEPLATE AND THE GLENOSPHERE (WHICH WAS UNABLE TO BE REMOVED) WERE THIRD-PARTY COMPONENTS. THE PATIENT WAS IRRIGATED AND DEBRIDED IN A ONE STAGE INFECTION PROCEDURE. A NEW 14X150 REVISION STEM WAS TRAILED AND IMPLANTED WITH A SHORT REVERSE HUMERAL BODY AND +3-40 POLY LINER. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1964. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 21459494 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110598. One submission often covers many models, so check the product and lot details in each record.

• Z-1711-2016 · Apr 8, 2016 · Terminated
  SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.