SMR System 1322.09.460Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390274234), received between Jul 8, 2024 and Dec 19, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO CUFF FAILURE. DURING THE PROCEDURE, THE PREVIOUSLY IMPLANTED SMR ANATOMICAL CONFIGURATION WAS CONVERTED TO A REVERSE CONFIGURATION. THE SURGEON REMOVED THE HUMERAL HEAD AND ANATOMICAL BODY, ADDRESSED SOFT-TISSUE DEBRIS AND IMPLANT WEAR, ASSESSED THE GLENOID SIDE, AND IMPLANTED THE REVERSE COMPONENTS FOLLOWING STANDARD REVERSE SHOULDER TECHNIQUE. TRIAL LINERS WERE USED TO ACHIEVE OPTIMAL JOINT STABILITY BEFORE IMPLANTING THE DEFINITIVE LINER. THE FOLLOWING SMR ANATOMICAL IMPLANTS WERE REMOVED: - SMR HUMERAL HEAD Ø46 MM (PRODUCT CODE: 1322.09.460, LOT #: 1415123 - STER. #: (B)(4)) SOLD IN US. - SMR ECC. ADAPTOR TAPER STANDARD (PRODUCT CODE: 1330.15.274, LOT #: 1500218 - STER. #: (B)(4)) SOLD IN US. - SMR FINNED HUMERAL BODY (PRODUCT CODE: 1350.15.110, LOT #: 1504258 - STER. #: (B)(4)) SOLD IN US. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2015. THE PATIENT IS A MALE,72 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23849604 ↗
• InjuryMay 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  UPCOMING SHOULDER REVISION SURGERY DUE TO ROTATOR CUFF TEAR. PATIENT UNDERWENT UNEVENTFUL STEMLESS TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2024. POST OPERATIVELY, THE PATIENT WAS NOTED TO HAVE RECURRENT SHOULDER PAIN AND WEAKNESS, DIAGNOSED WITH A ROTATOR CUFF TEAR. THE REVISION SURGERY HAS NOT BEEN PERFORMED YET. THE PATIENT HAS THE FOLLOWING COMPONENTS CURRENTLY IMPLANTED: SMR HUMERAL HEAD Ø46 MM (PART CODE: 1322.09.460, LOT NUMBER: 2402987, STERILIZATION: 2400067). TT HYBRID CEM. GLENOID SMALL (PART CODE: 1379.59.110, LOT NUMBER: 2405576, STERILIZATION: 2400060). SMR STEMLESS - 2MM ECC. ADAPTOR (PART CODE: 1335.15.202, LOT NUMBER: 2419850, STERILIZATION 2400181). - SMR STEMLESS - STEML. CORE #M (PART CODE: 1355.14.135, LOT NUMBER: 2332476, STERILIZATION 2400065). THE PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1960. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 22114664 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, SHOULDER REVISION SURGERY FOR CONVERSION OF TSA (TOTAL SHOULDER ARTHROPLASTY) TO RSA (REVERSE SHOULDER ARTHROPLASTY) DUE TO ROTATOR CUFF FAILURE. METAL ON METAL WEAR, MINOR. PREVIOUS SURGERY PERFORMED ON (B)(6) 2017. DEVICES EXPLANTED DURING REVISION SURGERY: SMR HUMERAL HEAD Ø46 MM (PRODUCT CODE: 1322.09.460 - LOT. 1605920) - SOLD IN US. SMR CEMENTLESS FINNED STEM (PRODUCT CODE: 1304.15.190 - LOT. 1610241) - SOLD IN US. SMR ECC.ADAPTOR TAPER STANDARD (PRODUCT CODE: 1330.15.274 - LOT. 1609802) - SOLD IN US. SMR FINNED HUMERAL BODY (PRODUCT CODE: 1350.15.110 - LOT. 1609730) - SOLD IN US. SMR UNCEMENT. GLENOID #SMALL-R (PRODUCT CODE: 1375.20.005 - LOT. 1616516) - NOT SOLD IN US. LINER F. MET.BACK GLEN.SMALL-R (PRODUCT CODE: 1377.50.005 - LOT. 16AT0K3) - SOLD IN US. BONE SCREW Ø6,5 H.20MM (PRODUCT CODE: 8420.15.010 - LOT. 1617940) - SOLD IN US. BONE SCREW Ø6,5 H.25MM (PRODUCT CODE: 8420.15.020 - LOT. 1700026) - SOLD IN US. PATIENT: FEMALE, 72 YEARS OLD, ACTIVITY LEVEL: ACTIVE, APPROXIMATE HEIGHT (M): 1.61, APPROXIMATE WEIGHT AT THE TIME OF PREVIOUS. SURGERY (KG): 63.50, APPROXIMATE WEIGHT AT THE TIME OF REVISION SURGERY (KG): 59.70 EVENT OCCURRED IN CANADA.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 19688296 ↗

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.