SMR System 1304.15.180Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390270816), received between Feb 20, 2026 and Apr 2, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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 16, 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.

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

  TOTAL SHOULDER REVISION SURGERY OF AN SMR ANATOMIC PROSTHESIS WAS PERFORMED ON (B)(6) 2026, DUE TO INFECTION. DURING THE PROCEDURE, THE HUMERAL HEAD PROSTHESIS, ANATOMIC BODY PROSTHESIS, POLY ANATOMIC LINER, BASEPLATE SCREWS, BASEPLATE, AND HUMERAL STEM WERE EXPLANTED, AND AN ANTIBIOTIC-LOADED CEMENT SPACER WAS IMPLANTED. THE FOLLOWING PRODUCTS WERE REPORTED AS INVOLVED IN THE EVENT AND EXPLANTED: · SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.180, BATCH NO. 0300869, STERILIZATION NO. (B)(4)). · SMR ECC. ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.274, BATCH NO. 0301405, STERILIZATION NO. (B)(4)). · SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, BATCH NO. 0301593, STERILIZATION NO. (B)(4)). · SMR UNCEMENT. GLENOID # STD (PRODUCT CODE 1375.20.010 BATCH NO. 0302079, STERILIZATION NO. (B)(4)). ACCORDING TO THE INFORMATION RECEIVED FROM THE COMPLAINT SOURCE, THE INFECTION ORIGINATED FROM A WOUND AND SUBSEQUENTLY INVOLVED THE JOINT. THE EXACT DATE OF THE PREVIOUS SURGERY IS UNKNOWN; HOWEVER, THE DEVICES HAD REPORTEDLY REMAINED IN SITU FOR APPROXIMATELY 10 TO 15 YEARS. EVENT HAPPENED IN AUSTRALIA

  Patient problems: Medical device site infection

  MAUDE report 24763575 ↗
• InjuryFeb 25, 2026Inadequacy of Device Shape and/or Size

  SECOND STAGE REVISION SURGERY WAS PERFORMED ON JANUARY 6TH 2026 IN A TWO STAGE REVISION. ORIGINAL SURGERY IS UNKNOWN, AS WELL AS FIRST STAGE REVISION SURGERY DATE AND REASON. PATIENT ORIGINALLY HAD A LIMA ANATOMIC SHOULDER PROSTHESIS WITH CEMENTED 3-PEGGED GLENOID. PRIOR REVISION WAS PERFORMED TO REMOVE GLENOID AND THE DEFECT WAS PACKED WITH BONE GRAFT. DURING CURRENT REVISION, THE SURGEON ATTEMPTED TO CONVERT THE PROSTHESIS TO A REVERSE CONFIGURATION EXPLANTING THE ORIGINAL SMR TRAUMA HUM. BODY # MEDIUM (PART NUMBER 1350.15.010), NEUTRAL ADAPTOR TAPER STANDARD ((PART NUMBER 1330.15.270) AND SMR HUMERAL HEAD Ø48 MM (PART NUMBER 1322.09.480), BUT THE REVERSE BODY WAS DEEMED TO BE TOO PROUD TO REDUCE THE SHOULDER, THEREFORE THE SMR CEMENTLESS FINNED STEM (PART NUMBER 1304.15.180) WAS REPLACED WITH A TORNIER REVIVE STEM. PRIMA TT COMPONENTS WERE SUCCESSFULLY IMPLANTED ON THE GLENOID SIDE. THE PATIENT IS MALE, DATE OF BIRTH (B)(6) 1946. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442715 ↗
• InjuryFeb 20, 2026Patient Device Interaction Problem

  AN SMR REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DUE TO IMPLANT LOOSENING. ACCORDING TO THE SOURCE OF THECOMPLAINT, DURING THE REVISION PROCEDURE THE GLENOSPHERE AND HUMERAL COMPONENTS WERE EXPLANTED AND REPLACED, AND A LONGCEMENTED STEM (14 × 180 MM) WAS IMPLANTED.THE FOLLOWING DEVICES WERE EXPLANTED IN THE PROCEDURE:· SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.180, LOT #2114810 - STER. 2100272) SOLD IN US· SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #2124196 - STER. 2100381)· SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.010, LOT #21AT03G - STER. 2100194)· SMR ECCENTRIC GLENOSPHERE Ø 36 MM (PRODUCT CODE 1376.09.031, LOT #2009277 - STER. 2000208)THE PREVIOUS SHOULDER SURGERY WAS PERFORMED ON(B)(6) 2022.THE PATIENT IS A 73-YEAR-OLD MALE.EVENT HAPPENED IN AUSTRALIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401879 ↗