SMR System 1361.50.820Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390273640), received between Mar 19, 2026 and Apr 22, 2026 — classified as 2 injuries.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER DISLOCATION. PREVIOUS SURGERY OCCURRED ON (B)(6) 2026 WHEN PATIENT UNDERWENT REVERSE TOTAL SHOULDER ARTHROPLASTY WITH SMR HUMERAL COMPONENTS CONSISTING OF: - REVISION STEM DIA16MM H 150MM (PN 1308.15.164, LOT 2510198, STERILIZATION (B)(6). - SMR 140° HUMERAL BODY REVERSE (PN 1352.15.011, LOT 2520339, STERILIZATION (B)(6). - EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001, LOT 2516851, STERILIZATION (B)(6) - RETENTIVE LINER +6MM 36MM (PN 1361.50.820, LOT 14AT4DB, STERILIZATION (B)(6). NO INFORMATION REGARDING ORIGINAL GLENOID COMPONENTS WAS PROVIDED. DURING REVISION ALL THE ABOVE MENTIONED COMPONENTS WERE REMOVED AND REPLACED WITH SIMILAR ITEMS, WITH EXCEPTION OF A 140° FINER HUMERAL BODY REVERSE (PN 1352.15.051) AND A RETENTIVE LINER +6MM DIA40MM (PN 1365.50.821) FOR SIZE COMPATIBILITY WITH THE DJO 40MM LATERALIZED GLENOSPHERE THAT HAS BEEN IMPLANTED. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1940. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 24950298 ↗
• InjuryMar 19, 2026Detachment of Device or Device Component

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DISASSEMBLY OF COMPONENTS. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025. DURING ORIGINAL SURGERY FOLLOWING HUMERAL COMPONENTS WERE IMPLANTED: FINNED STEM DIA 17 MM L. 80 MM (PN 1304.15.170, LOT. 2422779, STER. 2400186). RETENTIVE LINER + 6MM (PN 1361.50.820, LOT. 23AT1LC, STER. 2400073). 140° HUMERAL REVERSE BODY (PN 1352.15.011, LOT. 2500053, STER. 2436410). IN COMBINATION WITH GLENOID COMPONENTS FROM ANOTHER MANUFACTURER. DURING REVISION THE SURGEON REMOVED THE ABOVE-MENTIONED RETENTIVE LINER AND REPLACED WITH EXTENTION AND RETENTIVE REVERSE: RETENTIVE REVERSE LINER (PN1360.54.816). EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001). SURGERY WAS COMPLETED AS INTENDED. EVENT OCCURRED IN UNITED STATES.

  Patient problems: Loose body in joint

  MAUDE report 24638848 ↗

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.