SMR System 1377.50.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390272674), received between Nov 8, 2024 and Mar 27, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Degraded; Unstable; Device Dislodged or Dislocated; Degraded; Unstable; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO MULTIPLE COMPLICATIONS, INCLUDING SUSPECTED SUBSCAPULARIS FAILURE, IMPLANT INSTABILITY, POLYETHYLENE LOADING FAILURE, POLYETHYLENE DISRUPTION, AND BASEPLATE FAILURE. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT INITIALLY UNDERWENT PRIMARY SMR ANATOMIC SURGERY IN 2014. IN 2022, AFTER EXPERIENCING TWO FALLS, THE PATIENT CONSULTED THE SURGEON BUT INITIALLY CHOSE NOT TO UNDERGO REVISION SURGERY. THE FOLLOWING COMPONENTS WERE INVOLVED IN THIS CASE: SMR UNCEMENTED GLENOID #SMALL-R (CODE: 1375.20.005, LOT N. 1400108, STERILIZATION N. 1400054) LINER F. METAL BACK GLENOID SMALL-R (CODE: 1377.50.005, LOT N. 1313557, STERILIZATION N. 1300306). SOLD IN US. SMR HUMERAL HEAD Ø44 MM (PART CODE: 1322.09.440). NEUTRAL ADAPTOR TAPER STANDARD (PART CODE: 1330.15.270). SMR FINNED HUMERAL BODY (PART CODE: 1350.15.110). SMR CEMENTLESS FINNED STEM (PART CODE: 1304.15.170). BONE SCREW Ø6.5 H.20MM (PART CODE: 8420.15.010). BONE SCREW Ø6.5 H.25MM (PART CODE: 8420.15.020). PATIENT DETAILS: FEMALE, 85 YEARS OLD, BMI: 41.4 (PRE-OP, (B)(6) 2024). THE EXACT IMPLANTATION DATE OF THE ABOVE-LISTED COMPONENTS IN 2014 WAS NOT PROVIDED BY THE COMPLAINT S

  Patient problems: Joint Dislocation

  MAUDE report 21708943 ↗
• InjuryJan 7, 2025Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2024, SHOULDER REVISION SURGERY FOR CONVERSION OF TSA (TOTAL SHOULDER ARTHROPLASTY) TO RSA (REVERSE SHOULDER ARTHROPLASTY) DUE TO WEAR OF THE LINER (PROD. CODE 1377.50.005, BATCH N. 15AT07U, STER.(B)(6)), CUFF TEAR AND METALLOSIS. PREVIOUS SURGERY PERFORMED ON (B)(6) 2016. TOGETHER WITH THE LINER THE FOLLOWING DEVICES WERE EXPLANTED: · SMR HUMERAL HEAD Ø52 MM (PRODUCT CODE: 1322.09.520, BATCH N. 1500216, STER.(B)(6)) - SOLD IN US. · SMR FINNED HUMERAL BODY (PRODUCT CODE: 1350.15.110, BATCH N. UNKNOWN) - SOLD IN US . PATIENT IS MALE, 74 AGE, HEIGHT 169 CM, WEIGHT 85 KG, VERY ACTIVE.

  Patient problems: Metal Related Pathology; Muscle/Tendon Damage

  MAUDE report 21091073 ↗
• InjuryNov 8, 2024Break; Degraded; Device Dislodged or Dislocated; Break; Degraded; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY OCCURRED ON (B)(6) 2024, DUE TO SUCCESSIVELY INCREASING DISCOMFORT IN THE LAST TWO YEARS WITH MECHANICAL SYMPTOMS. COMPLAINT SOURCE REPORTED THAT DURING REVISION SURGERY LINER F. MET.BACK GLEN.SMALL-R (PRODUCT CODE: 1377.50.005, LOT. 17AT24T - STER. (B)(4)) RESULTED LUXATED WITH BROKEN PEGS AND PARTS OF THE BASE PLATE WERE WORN DOWN. THE HEAD OF THE TOP SCREW WAS ALMOST COMPLETELY GONE. PRONOUNCED METALLOSIS AND THE MASSIVE METALLOSIS WAS SUBCOMPLETELY CLEANED. THE BOTTOM SCREW WAS VERY TIGHT BUT COULD BE UNSCREWED IN ITS ENTIRETY WITHOUT DEFORMATION. THE HEAD OF THE TOP SCREW WAS RUNDOWN AND PENETRATES THE UPPER HOLE OF THE STANDARD PLATE. THE BASEPLATE WAS CHISELED, AND THE TOP SCREW WAS UNSCREWED. THE POSSIBILITY OF BEING ABLE TO IMPLANT A 360 WAS EVALUATED, BUT WHEN TRYING TO PLACE THE GLENOSPHERE THE OPERATOR NOTICED THAT THE UPPER SCREW HAD PENETRATED THE CORTEX, AND THE CONSTRUCTION WAS LOOSE. THE UPPER SCREW WAS REMOVED, AND A CUSTOM GLENOID METAL BACK WAS REQUESTED TO LIMACORPORATE. DEVICES REPORTED BELOW WERE IMPLANTED DURING PREVIOUS SURGERY PERFORMED ON (B)(6) 2018, DUE TO MODERATE GLENOHUMERAL OSTEOARTHRITIS. · LINER F. MET.BACK GLEN.SMALL-R (

  Patient problems: Joint Dislocation

  MAUDE report 20641114 ↗