SMR Shoulder Humeral Head (REF 1322.09.520)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390001427), received between Oct 15, 2024 and Jan 2, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE. THE PATIENT HAD FAILED ROTATOR CUFF, AND THE IMPLANT WAS CONVERTED TO REVERSE CONFIGURATION. ACCORDING TO THE INFORMATION RECEIVED, THE COMPONENTS REMOVED DURING THE HEREBY REPORTED REVISION ARE THE FOLLOWING: SMR HUMERAL HEAD Ø52 MM (PART CODE 1322.09.520, LOT NUMBER 1615749, STERILIZATION UNKNOWN) NEUTRAL ADAPTOR TAPER STANDARD (PART CODE 1330.15.270, LOT NUMBER 2220568, STERILIZATION (B)(4)). SMR TRAUMA HUM. BODY # SHORT (PART CODE 1350.15.030, LOT NUMBER 2220647, STERILIZATION (B)(4)). LINER F.MET.BACK GLEN.STANDARD (PART CODE 1377.50.010, LOT NUMBER 21AT27B, STERILIZATION (B)(4)) PREVIOUS SURGERY PERFORMED ON (B)(6) 2024. THE PATIENT IS A MALE, DATE OF (B)(6) 1964. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23942282 ↗
• InjuryMar 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY OF A SMR ANATOMIC PROSTHESIS PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE. IT WAS REPORTED THAT THE SUBSCAPULARIS HAS FAILED 10 YEARS POST PRIMARY SURGERY. THE FOLLOWING DEVICES WERE REMOVED AND THE PROSTHESIS WAS CONVERTED TO REVERSE CONFIGURATION: SMR HUMERAL HEAD Ø52 MM (PRODUCT CODE: 1322.09.520, LOT#: 1500216 - STER. 1500066). SMR CEMENTLESS FINNED STEM (PRODUCT CODE: 1304.15.220, LOT#: 1414382 - STER. 1500033). SMR ECCENTRIC ADAPTOR TAPER STANDARD (PRODUCT CODE: 1330.15.278, LOT#:1502057 - STER. 1500122). SMR TRAUMA HUMERAL BODY# SHORT (PRODUCT CODE: 1350.15.030, LOT#: 1003333 - STER. 1500245). CEMENTED GLENOID 3 PEGS STANDARD (PRODUCT CODE 1379.51.010, LOT#: 14L0379 - STER. 1400294). ACCORDING TO THE RECEIVED INFORMATION, ALL COMPONENTS WERE REMOVED DUE TO THE PRIMARY IMPLANTS BEING IN TOO HIGH. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2015. PATIENT IS A MALE, 67 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 21688255 ↗
• InjuryMar 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  SHOULDER REVISION DUE TO CUFF FAILURE PERFORMED ON (B)(6) 2025. THE PATIENT HAD SUBSCAPULARIS TEAR, AND THE ANATOMIC TOTAL SHOULDER WAS REVISED TO REVERSE TOTAL SHOULDER. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED WITH REVERSE COMPONENTS: SMR HUMERAL HEAD Ø52 MM (PART CODE 1322.09.520, LOT NUMBER 1309283, STERILIZATION (B)(4)). SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.274, LOT NUMBER 141061, STERILIZATION (B)(4)). SMR FINNED HUMERAL BODY (PART CODE 1350.15.110, LOT NUMBER 1409544, STERILIZATION (B)(4)). LINER F. MET.BACK GLEN.SMALL (PART CODE 1377.50.020, LOT NUMBER 1407195, STERILIZATION (B)(4)). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2015. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1945. EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 21663546 ↗
• InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY OF A SMR STEMLESS ANATOMIC PROSTHESIS PERFORMED ON (B)(6) 2024, DUE TO CUFF FAILURE. THE PATIENT HAD A CUFF TEAR AND SURGEON DID A CONVERSION ANATOMIC TO REVERSE WITH THE HYBRID BASEPLATE. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR HUMERAL HEAD Ø52 MM (PRODUCT CODE 1322.09.520, LOT #1919682 - STER. (B)(4)). SMR STEMLESS - 2MM ECC.ADAPTOR (PRODUCT CODE 1335.15.202, LOT #1807915 - STER. (B)(4)). TT HYBRID CEMENTED GLENOID SMALL (PRODUCT CODE 1379.59.110, LOT #2004267 - STER. (B)(4)). A TT HYBRID REVERSE BASEPLATE SMALL, TWO BONE SCREWS, A REVERSE HP GLENOSPHERE 40MM AND A REVERSE LINER FOR STEMLESS CORE #LONG 40MM WERE IMPLANTED. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A MALE, 63 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20448966 ↗

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.