SMR Shoulder Humeral Head (REF 1322.09.440)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390001380), received between Jan 7, 2025 and Jan 13, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY OF A SMR STEMLESS ANATOMIC IMPLANT PERFORMED ON (B)(6) 2024, DUE TO CUFF FAILURE. THE CUFF FAILED APPROXIMATELY 4 YEARS POST THE PRIMARY SURGERY. THE HYBRID POLY WAS REMOVED, LEAVING THE PEG IN SITU, THE HUMERAL HEAD AND THE ADAPTOR WERE EXPLANTED: SMR HUMERAL HEAD Ø44 MM (PRODUCT CODE: 1322.09.440, LOT#: 1905765 - STER. 1900200). SMR STEMLESS - 2MM ECCENTRICAL ADAPTOR (PRODUCT CODE: 1335.15.202, LOT#: 1816780 - STER. 1800383). · TT HYBRID CEMENTED GLENOID #S LOW+2 (PRODUCT CODE: 1379.59.102, LOT#: 1907961 - STER. 1900214). THE IMPLANT WAS CONVERTED TO REVERSE CONFIGURATION USING A HYBRID REVERSE BASEPLATE WITH TWO SCREWS, A GLENOSPHERE AND A REVERSE LINER. THE STEMLESS CORE WAS LEFT IN SITU. PATIENT'S CLINICAL DETAILS ARE UNKNOWN. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2019. EVENT HAPPENED IN (B)(6).

  Patient problems: Loss of Range of Motion; Muscle/Tendon Damage

  MAUDE report 21136184 ↗
• InjuryJan 7, 2025Device 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. IT WAS REPORTED THAT A CONVERSION FROM ANATOMICAL TO REVERSE WAS PERFORMED. THE FOLLOWING DEVICES GOT EXPLANTED: SMR HUMERAL HEAD Ø44 MM (PRODUCT CODE: 1322.09.440, LOT#: 1412462 - STER. 1500006). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE: 1330.15.270, LOT#: 1411227 - STER. 1400321). SMR FINNED HUMERAL BODY (PRODUCT CODE: 1350.15.110, LOT#: 1414868 - STER. 1500036). LINER FOR METALBACK GLENOID STANDARD (PRODUCT CODE: 1377.50.010, LOT#: 1407634 - STER. 1400232). THE SURGEON WAS SATISFIED WITH THE FINAL STABILITY AND RANGE OF MOTION. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2015. PATIENT IS A MALE, 68 YEARS OLD. NO COMORBIDITIES WERE REPORTED. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 21091069 ↗

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.