SMR System 1352.15.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390272551), received between Jul 1, 2025 and Jul 29, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 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.

• InjuryJul 29, 2026Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  The complaint source reported that a first-stage shoulder revision surgery was performed on (b)(6) 2026 due to a dislocation. During the procedure, the glenosphere, custom screw, liner, short reverse body, and associated screw were explanted. A new screw from a standard reverse body was inserted into the stem, which was left in situ.According to the surgeon, a possible contributing factor was an infection. The surgeon also noted that the reverse body screw was not fully engaged and that insufficient bone was removed from the area at reverse body / stem connection.A new custom screw has been requested to LimaCorporate for the planned second-stage revision surgery.Hereby the list of devices that were implanted in the previous surgery: SMR REVERSE HUMERAL BODY SHORT (Product Code: 1352.15.005, Lot: 2602989 - Ster: 260004) - Sold in USSMR REVERSE LINER STANDARD (Product Code: 1360.50.010, Lot: 24at2c8 - Ster: 2400162) - Not sold in USSMR ECCENT. GLENOSPHERE Ø 36MM (Product Code: 1376.15.031, Lot: 2601926 - Ster:2600023) - Not sold in USCORTIC.BONE SCREW D.5 L.32 MM (Product Code: 8432.15.032, Lot: 2521662 - Ster: 2500150) - Sold in USCORTIC.BONE SCREW D.5 L.34 MM (Product Code: 8432.15

  Patient problems: Abnormal Vaginal Discharge; Joint Dislocation

  MAUDE report 50069636 ↗
• InjuryMar 12, 2026Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DISTAL HUMERUS FRACTURE WITH CONSEQUENT SHOULDER INSTABILITY. DATE OF ORIGINAL SURGERY IS UNKNOWN. DURING THE REVISION SURGERY PRE-EXISTING SMR SHORT REVERSE HUMERAL BODY (PN 1352.15.005) AND SMR REVERSE LINER 36 MM + 6 (PN 1360.50.820) WERE EXPLANTED AND REPLACED WITH NEW 140° SHORT REVERSE HUMERAL BODY (PN 1352.15.015) AND REVERSE LINER STANDARD 36 MM (PN 1360.50.810). REVISION WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1948. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Bone Fracture(s)

  MAUDE report 24584226 ↗
• InjuryJul 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO DISLOCATION OF AN SMR REVERSE PRODUCTS IN COMBINATION WITH PROMADE COMPONENTS (CMD 24-1350). THE INITIAL SURGERY HAD TAKEN PLACE ON (B)(6) 2025. A FEW WEEKS LATER, THE PATIENT RETURNED TO THE HOSPITAL, AND X-RAYS CONFIRMED THE DISLOCATION. REMOVED THE EXPLANTS BELOW: SMR REVERSE HUMERAL BODY SHORT (CODE 1352.15.005, LOT N. 2430835, STER. N. (B)(4) - SOLD IN US SMR REVERSE HP GLENOSPH. 40 MM (CODE 1374.50.400, LOT N. 2434844, STER. N. (B)(4) - NOT SOLD IN US. PATIENT: FEMALE, DOB: (B)(6) 1964. THE SAME PATIENT UNDERWENT A PREVIOUS REVISION SURGERY DUE TO DISLOCATION. FOR THIS EVENT COMPLAINT WITH REFERENCE (B)(4) HAS BEEN REGISTERED (MDR REPORT NUMBER: 3008021110-2025-00083). EVENT HAPPENED IN UNITED KINGDOM.

  Patient problems: Joint Dislocation

  MAUDE report 22370033 ↗

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.