SMR System 1352.15.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390272568), received between Mar 27, 2025 and May 26, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Degraded” (1 report).

1 other recall cover devices cleared under the same FDA submission (K110598); 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.

• InjuryMay 26, 2026Insufficient Device Problem Information

  REVISION SURGERY HEREBY REPORTED HAS BEEN PERFORMED ON (B)(6) 2026, DUE TO UNKNOWN REASONS. PATIENT WAS ORIGINALLY IMPLANTED WITH SMR REVERSE PROSTHESIS. ORIGINAL PROSTHETIC ASSEMBLY CONSISTED OF BASEPLATE, LATERALIZED CONNECTOR +4 MM, GLENOSPHERE ECCENTRIC DIA 40 MM AND SMR HUMERAL BODY REVERSE (PART NUMBER 1352.15.010, LOT UNKNOWN). 9/10 YEARS LATER, FIRST REVISION SURGERY OCCURRED ((B)(6) 2025) DUE TO INFECTION: HUMERAL BODY HAS BEEN EXPLANTED AND REPLACED WITH A NEW ONE (COMPLAINT ASSOCIATED TO MFR # 3008021110-2026-00010). ON (B)(6) 2026, HEREBY REPORTED SECOND REVISION SURGERY HAS BEEN PERFORMED AND PRE-EXISTING HUMERAL BODY (PN 1352.15.010, LOT. 2511798, STER. 2500105) AND GLENOID COMPONENTS HAS BEEN EXPLANTED AND REPLACED WITH THE FOLLOWING: 140° HUMERAL BODY FINNED REVERSE (PN 1352.15.051); REVERSE LINER + 3 MM DIA 40 MM (PN 1365.50.815); GLENOSPHERE ECCENTRICAL DIA 40 MM (PN 1376.09.041); CONNECTOR + SCREW (PN 1374.15.305); TT BASEPLATE (PN 1375.15.305); BONE SCREW (PN 8420.15.050); BONE SCREW (PN 8420.15.030). PATIENT IS MALE, DATE OF BIRTH (B)(6) 1962. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Insufficient Information

  MAUDE report 25278965 ↗
• InjuryJan 26, 2026Degraded; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO PAIN. PREVIOUS SURGERY WAS A REVERSE SHOULDER ARTHROPLASTY IN 2017, HOWEVER IMPLANT RECORD WITH COMPLETE PRODUCT INFORMATION OF ORIGINAL ASSEMBLY COULD NOT BE RECOVERED. PROSTHESIS WAS REPORTED TO HAVE WORKED WELL FOR MANY YEARS. RECENTLY PATIENT WAS EXPERIENCING PAIN. AS A CONSEQUENCE, VISIT AND XRAYS WERE PERFORMED AND INDICATED LYSIS, POSSIBLY CAUSED BY NOTCHING OR VOLUMETRIC WEAR. SURGEON REMOVED THE PRE-EXISTING SMR REVERSE HUMERAL BODY (PART NUMBER 1352.15.010), THE SMR REVERSE LINER STD D.40MM (PART NUMBER 1365.50.810) AND THE SMR GLENOSPHERE Ø40MM SMALL-R (PART NUMBER 137409115) AND IMPLANTED A NEW 140° HUMERAL REVERSE BODY (PART NUMBER 1352.15.015), REVERSE LINER +3MM (PART NUMBER 1360.50.815), LATERALIZER +2MM CONNECTOR (PART NUMBER 1374.15.312) AND 36MM GLENOSPHERE (PART NUMBER 1374.09.111). ACCORDING TO INFORMATION PROVIDED, NEITHER THE 140° HUMERAL BODY IMPLANT NOR THE LATERALIZED CONNECTOR WERE AVAILABLE AT THE TIME OF PRIMARY SURGERY, OTHERWISE SURGEON WOULD HAVE USED THEM FOR ORIGINAL IMPLANT. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1946. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Implant Pain

  MAUDE report 24178571 ↗
• InjuryJan 22, 2026Mechanics Altered

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO SCAPULAR NOTCHING. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2023, HOWEVER NO COMPLETE INFORMATION REGARDING ORIGINAL IMPLANT WAS AVAILABLE. DURING REVISION THE EXISTING SMR REVERSE HUMERAL BODY (PART NUMBER: 1352.15.010) AND REVERSE LINER +3MM (PART NUMBER: 1360.50.815) WERE REMOVED AND REPLACED WITH A 140° REVERSE HUMERAL BODY SHORT (PART NUMBER: 1352.15.015) AND A THICKER REVERSE LINER +6MM DIA 36MM (PART NUMBER: 1360.54.820). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH ON (B)(6) 1950. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Impingement

  MAUDE report 24145657 ↗
• InjuryMar 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025. PATIENT HAD INFECTION. THE FOLLOWING COMPONENTS WERE INVOLVED IN THE EVENT: SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 2431460, STERILIZATION (B)(4)); SMR REVERSE LINER + 3 MM (PART CODE 1360.50.815, LOT NUMBER 23AT40H, STERILIZATION (B)(4)). THERE WERE NO DELAYS IN SURGERY, NO PIECES FRAGMENTED OR BROKE, THERE WAS ANOTHER DEVICE AVAILABLE, THE SURGERY WAS COMPLETED AS INTENDED, AND DEVICE WAS INSPECTED PRIOR TO USE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1965. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 21709129 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110598. One submission often covers many models, so check the product and lot details in each record.

• Z-1711-2016 · Apr 8, 2016 · Terminated
  SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.