SMR Shoulder Eccentrical AdaptorRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390001922), received between Apr 30, 2025 and Apr 30, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO DISASSEMBLY OF COMPONENTS. THE MORSE TAPER CONNECTION DISENGAGED. THE FOLLOWING COMPONENTS WERE REMOVED: SMR FINNED STEM SHORT D.21 (PART CODE: 1304.15.021, LOT NUMBER: 2016623, STERILIZATION 2000409). SMR HUMERAL HEAD DIA.54 MM (PART CODE: 1322.09.540, LOT NUMBER: 1506372, STERILIZATION 2000414). SMR ECC.ADAPTOR TAPER STANDARD (PART CODE: 1330.15.272, LOT NUMBER: 2331971, STERILIZATION 2400033). SMR FINNED HUMERAL BODY (PART CODE: 1350.15.110, LOT NUMBER: 2101472, STERILIZATION 2100098). THE ABOVE-MENTIONED COMPONENTS WERE REPLACED BY THE FOLLOWING NEW ONES: SMR FINNED STEM DIA 21MM L.80 (PART CODE: 1304.15.210, LOT NUMBER: 2320690, STERILIZATION 2400025). SMR FINNED HUMERAL BODY (PART CODE: 1350.15.110, LOT NUMBER: 2405095, STERILIZATION 2400062). SMR ECC. ADAPTOR TAPER 2MM (PART CODE: 1330.15.272, LOT NUMBER: 2414583, STERILIZATION 2400152). SMR HUMERAL HEAD DIA.54 MM (PART CODE: 1322.09.540, LOT NUMBER: 1503494, STERILIZATION 2000263). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1972. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 21932973 ↗

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.