SMR Shoulder Humeral Head (REF 1322.09.420)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08033390001373), received between Oct 15, 2024 and Jul 1, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO CUFF FAILURE. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL ASSEMBLY. IN SUBSEQUENT YEARS, THE PATIENT EXPERIENCED SUBSCAPULARIS FAILURE REQUIRING REVISION. DURING THE SURGERY TO ADDRESS THE SUBSCAPULARIS, THE SURGEON DECIDED TO REPLACE THE EXISTING 42MM HUMERAL HEAD (PN 1322.09.420) WITH ADAPTOR TAPER +4MM (PN 1330.15.274) WITH A SMALLER ONE (40MM H13 ECCENTRICAL 2MM HUMERAL HEAD, PN 1321.09.402). THE PRE-EXISTING TRAUMA HUMERAL BODY #MEDIUM (PN 1350.15.010) HAS ALSO BEEN REPLACED WITH A SHORT ONE (PN 1350.15.030). SUBSCAPULARIS WAS REPAIRED; ASSEMBLY WAS REDUCED IN SIZE AND SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1948. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 25680177 ↗
• InjuryMay 27, 2026Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO SHOULDER DISLOCATION. PREVIOUS SURGERY OCCURRED ON (B)(6) 2021, WHEN THE FOLLOWING ANATOMIC ASSEMBLY WAS IMPLANTED: FINNED STEM DIA16MM L80 (PN 1304.15.160), HUMERAL BODY TRAUMA SHORT (PN 1350.15.030, LOT 1508788, STERILIZATION 2100166), ADAPTOR TAPER NEUTRAL (PN 1330.15.270, LOT 2013121, STERILIZATION 2000263), HUMERAL HEAD DIA 42MM (PN 1322.09.420, LOR 1917287, STERILIZATION 1900460), GLENOID METAL BACK SMALL-R (PN 1375.21.005), LINER FOR METAL BACK SMALL-R (PN 1377.50.005, LOT 20AT0XS, STERILIZATION 2000235). AFTER PATIENT DISLOCATION, THE SURGEON DECIDED TO PERFORM A CONVERSION TO REVERSE CONFIGURATION FOR STABILITY. THE ABOVE MENTIONED HUMERAL BODY, ADAPTOR TAPER, HUMERAL HEAD AND LINER FOR METAL BACK WERE REMOVED AND REPLACED WITH HUMERAL BODY REVERSE (PN 1352.14.010), RETENTIVE LINER +6MM (PN 1361.50.820), CONNECTOR LATERALIZED+2MM SMALL-R (PN 1374.15.312) AND GLENOSPHERE DIA36MM (PN 1374.09.111). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1959. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 25297977 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO ROTATOR CUFF TEAR PERFORMED ON (B)(6) 2025. THE IMPLANTS WERE REPLACED BY REVERSE AND THE FOLLOWING COMPONENTS WERE REMOVED: LINER F. MET.BACK GLEN.SMALL-R (PART CODE 1377.50.005, LOT NUMBER 20AT1H5, STERILIZATION (B)(4), SMR HUMERAL HEAD DIA. 42 MM (PART CODE 1322.09.420, LOT NUMBER 2000676, STERILIZATION (B)(4), SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.274, LOT NUMBER 2005237, STERILIZATION (B)(4), SMR TRAUMA HUM. BODY # SHORT (PART CODE 1350.15.030, LOT NUMBER 1700882, STERILIZATION (B)(4). THE GLENOID COMPONENTS (SMR GLENOID PEG TT SMALL-R #S - PART CODE 1375.14.651, AND SMR GLENOID BASEPLATE SMALL-R - PART CODE 1375.15.605) WERE LEFT IN SITU. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1945. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 22288037 ↗
• InjuryMay 29, 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. IT WAS REPORTED THAT THE PATIENT TORE THEIR ROTATOR CUFF AND NEEDED A REVERSE TOTAL SHOULDER. THE FOLLOWING DEVICES WERE REMOVED: · SMR HUMERAL HEAD Ø42 MM (PRODUCT CODE 1322.09.420, LOT #2119265 - STER. 2100333). · LINER FOR METALBACK GLENOID STANDARD (PRODUCT CODE 1377.50.010, LOT #21AT2C8 - STER. 2200049). · SMR ADAPTOR TAPER (PRODUCT CODE AND LOT # UNKNOWN). · HUMERAL BODY (PRODUCT CODE AND LOT # UNKNOWN). THE PROSTHESIS WAS CONVERTED TO REVERSE CONFIGURATION: A DIA.36MM REVERSE LINER +6MM, A DIA.36MM GLENOSPHERE, A LATERALIZED CONNECTOR +4MM AND A REVERSE HUMERAL BODY WERE IMPLANTED. IT WAS REPORTED THAT THE PREVIOUS SURGERY WAS PERFORMED AT THE END OF (B)(6) 2025 (BUT THE EXACT DATE IS UNKNOWN). PATIENT IS A FEMALE, 64 YEARS OLD. EVENT HAPPENED IN THE US.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 22104932 ↗
• InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL PROSTHESIS PERFORMED ON (B)(6) 2024, DUE TO CUFF FAILURE. THE FOLLOWING DEVICES WERE REMOVED: · SMR HUMERAL HEAD Ø42 MM (PRODUCT CODE 1322.09.420, LOT #0401967 - STER. 0900223) · NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #0903172 - STER. 0900223) · SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT #0902887 - STER. 0900243) · L2 LINER FOR METALBACK (PRODUCT CODE 1377.51.060, LOT #0807573 - STER.0900023) THE PROSTHESIS WAS CONVERTED TO REVERSE USING A 36MM CONCENTRIC GLENOSPHERE WITH STANDARD CONNECTOR, A SHORT REVERSE HUMERAL BODY AND A 36+3MM REVERSE LINER. IT WAS STATED THAT THE STEM IN THE HUMERUS AND THE SMALL-SIZE METALBACK AND SCREWS IN THE GLENOID WERE WELL FIXED. THE SURGEON TOOK MULTIPLE SPECIMENS OF TISSUE AND THOROUGHLY WASHED THE WOUND. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2009. PATIENT'S CLINICAL DETAILS ARE UNKNOWN. EVENT HAPPENED IN NEW ZEALAND.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20448965 ↗
• InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL PROSTHESIS PERFORMED ON (B)(6) 2024, DUE TO CUFF FAILURE. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR HUMERAL HEAD Ø42 MM (PRODUCT CODE 1322.09.420, LOT#: 1211144 - STER. 1200305). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT#: 1305561 - STER. 1300219). SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT#: 1309184 - STER. 1300279). LINER FOR METALBACK GLENOID SMALL (PRODUCT CODE 1377.50.020, LOT#: 1203963 - STER. 1200179). IT WAS REPORTED THAT WHILE LOOSENING THE PROXIMAL BODY FROM THE HUMERUS WITH THE OSTEOTOME, THE HUMERUS SUSTAINED A FRACTURE, WHICH WAS FIXATED WITH MULTIPLE FIBER WIRE SUTURES. THE COMPLAINT SOURCE CONFIRMED THAT THERE WASN'T ANY MALFUNCTION OF INSTRUMENTS. THE PROSTHESIS WAS CONVERTED TO REVERSE USING A 40MM GLENOSPHERE, A CONNECTOR WITH SCREW, A TRAUMA REVERSE BODY AND A SHORT 40MM LINER. MULTIPLE MICROBIOLOGY SPECIMENS WERE TAKEN, AND A THOROUGH WASHOUT OF THE WOUND WAS PERFORMED. IT IS UNKNOWN HOW LONG THE CUFF FAILED BEFORE THE SURGERY TOOK PLACE. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2014. PATIENT IS A FEMALE, 71 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20448963 ↗

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-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.
• 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