SMR Shoulder Humeral Head (REF 1322.09.500)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390001410), received between May 20, 2025 and May 26, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K100858); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO ROTATOR CUFF FAILURE. PREVIOUS SURGERY OCCURRED ON (B)(6) 2021 FOR A TOTAL SHOULDER ARTHROPLASTY WITH SMR ANATOMIC COMPONENTS: GLENOID METAL BACK STD (PN 1375.21.010, LOT 2100627, STERILIZATION 2100093). LINER FOR METAL BACK STD (PN 1377.50.010, LOT 20AT3K4, STERILIZATION 2100083). FINNER STEM DIA20MM (PN 1304.15.200, LOT 1804199, STERILIZATION 1800137). FINNED HUMERAL BODY (PN 1350.15.110, LOT 2022509, STERILIZATION 2100045). ADAPTOR TAPER ECCENTRICAL (PN 1331.15.274, LOT 2016589, STERILIZATION 2100139). HUMERAL HEAD DIA50 (PPN 1322.09.500, LOT 1503172, STERILIZATION 2100045). DUE TO ROTATOR CUFF FAILURE, THE ORIGINAL IMPLANT HAS BEEN CONVERTED TO A REVERSE CONFIGURATION REMOVING THE ABOVE-MENTIONED HUMERAL HEAD, ADAPTOR TAPER AND LINER FOR METAL BACK AND REPLACING THEM WITH: CONNECTOR+ SCREW SMALL STD (PN 1374.15.310). GLENOSPHERE DIA36MM (PN 1374.09.111). REVERSE HUMERAL BODY (PN 1352.15.010). EXTENSION FOR REVERSE HUMERAL BODY (PN 1352.15.001). REVERSE LINER STANDARD (PN 1360.50.810). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1951. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 25278189 ↗
• InjuryJul 2, 2025Degraded; Degraded

  REVISION SURGERY DUE TO ROTATOR CUFF FAILURE AND WEAR OF THE LINER PERFORMED ON (B)(6) 2025. PATIENT NEEDED A CONVERSION FROM AN ANATOMICAL IMPLANT TO A REVERSE CONFIGURATION. THE ROTATOR CUFF HAD FAILED. ADDITIONALLY, IT WAS FOUND THAT THE LINER HAD WORN DOWN IN ONE OF THE CORNERS. THE FOLLOWING DEVICES WERE REMOVED AND REPLACED BY REVERSE COMPONENTS: - SMR HUMERAL HEAD DIA. 50 MM (PART CODE 1322.09.500, LOT NUMBER 2001533, STERILIZATION (B)(4)). - SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.272, LOT NUMBER 2002535, STERILIZATION (B)(4)). - LINER F. MET.BACK GLEN.LARGE (PART CODE 1377.50.030, LOT NUMBER 18AT1J9, STERILIZATION (B)(4)). - SMR FINNED HUMERAL BODY (PART CODE 1350.15.110, LOT NUMBER 2004189, STERILIZATION (B)(4)). PREVIOUS SURGERY PERFORMED ON (B)(6) 2020. THE FOLLOWING OTHER COMPONENTS WERE IMPLANTED DURING THE PREVIOUS SURGERY: - SMR METAL-BACK GLENOID LARGE (PART CODE 1375.21.030, LOT NUMBER 1906101, STERILIZATION (B)(4)). - SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.210, LOT NUMBER 1922729, STERILIZATION (B)(4)). THE PATIENT IS A MALE, DATE OF BIRTH JANUARY 28TH, 1955. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 22381176 ↗
• InjuryMay 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL PROSTHESIS PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE. NO TRAUMATIC EVENT REPORTED. THE FOLLOWING DEVICES WERE EXPLANTED: · SMR HUMERAL HEAD Ø50 MM (PRODUCT CODE 1322.09.500, LOT #1511345 - STER. 1700153) · NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #1702177 - STER. 1700114) · SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT #1211457 - STER. 1200358) · LINER FOR METALBACK GLENOID SMALL (PRODUCT CODE 1377.50.020, LOT #17AT1P5 - STER. 1700313) A 40MM ECCENTRIC GLENOSPHERE, STANDARD CONNECTOR, A SHORT PROXIMAL REVERSE HUMERAL BODY AND 40MM STANDARD VIT.E LINER WERE IMPLANTED. PATIENT IS A MALE, 53 YEARS OLD. HIS HISTORY OF SHOULDER HISTORY IS THE FOLLOWING: - PRIMARY SURGERY DONE ON (B)(6) 2013; - FIRST REVISION SURGERY ON (B)(6) 2018, DUE TO BREAKAGE OF THE LINER (EVENT REGISTERED AS COMPLAINT (B)(4); - SECOND REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE (HEREBY REPORTED). EVENT HAPPENED IN NEW ZEALAND.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 22051074 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100858. One submission often covers many models, so check the product and lot details in each record.

• Z-2539-2015 · Aug 14, 2015 · Terminated
  SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral
• Z-2540-2015 · Aug 14, 2015 · Terminated
  SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.