SMR System 1322.09.520Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390274296), received between Oct 21, 2025 and May 27, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K100858); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO ROTATOR CUFF FAILURE. PREVUOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION THE SURGEON EXPLANTED THE PRE-EXISTING TT HYBRID CEM. GLENOID STD LOW (PART NUMBER 1379.59.200), SMR HUMERAL BODY (PN1350.15.010), SMR ECC.ADAPTOR TAPER STD +2M (PART NUMBER 1330.15.272) AND THE SMR HUMERAL HEAD D.52 MM (PART NUMBER 1322.09.520) AND CONVERTED THE PROSTHESIS TO A REVERSE CONFIGURATION USING FOLLOWING COMPONENTS: TT HYBRID REVERSE BASEPLATE STD (PN 1379.15.170), GLENOSPHERE DIA40 (PN 1374.09.121), 140° REVERSE HUMERAL BODY (PN 1352.15.011), EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001), REVERSE LINER STD DIA40 (PN 1365.50.810)., THE DISTAL PORTION OF THE SMR CONSTRUCT WAS LEFT IN PATIENT FOR THE CONVERSION SINCE IT WAS WELL FIXED AND INTACT. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1953. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 25297978 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE CUFF FAILURE. THE FOLLOWING SMR STEMLESS ANATOMIC IMPLANTS WERE REMOVED AND REVERSE FROM STRYKER WAS IMPLANTED: · SMR HUMERAL HEAD Ø52 MM (PRODUCT CODE 1322.09.520, LOT # 1802753 - STER. (B)(4)) SOLD IN US. · SMR STEMLESS - NEUTRAL ADAPTOR (PRODUCT CODE 1335.15.200, LOT # 1713952 - STER. (B)(4)) SOLD IN US. · SMR STEMLESS - STEML. CORE #M (PRODUCT CODE 1355.14.235, LOT # 1714291 - STER. (B)(4)) SOLD IN US · CEMENTED GLENOID 3 PEGS SMALL (PRODUCT CODE 1379.51.020, LOT # 15AT1PG - STER. (B)(4)) PREVIOUS SURGERY WAS PERFROMED ON (B)(6) 2018. PATIENT IS A MALE, 67 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23345068 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO CUFF FAILURE. THE ANATOMIC HUMERAL HEAD, ANATOMIC BODY AND ANATOMIC GLENOID LINER WERE EXPLANTED: · SMR HUMERAL HEAD Ø52 MM (PRODUCT CODE 1322.09.520, LOT # 1509268 - STER. (B)(4)) SOLD IN US · LINER F.MET.BACK GLEN.STANDARD (PRODUCT CODE 1377.50.010, LOT #22AT2XT - STER. (B)(4)) SOLD IN US · SMR FINNED HUMERAL BODY (PRODUCT CODE 1304.15.220, LOT # 2022008- STER. (B)(4)) · SMR ECCENTRIC ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.272, LOT # 2003902- STER. (B)(4)). THE CONSTRUCT WAS CONVERTED TO A REVERSE, WITH A REVERSE BODY AND GLENOSPHERE IMPLANTED. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2023. PATIENT IS A MALE, 49 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23345067 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100858. One submission often covers many models, so check the product and lot details in each record.

• Z-2539-2015 · Aug 14, 2015 · Terminated
  SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral
• Z-2540-2015 · Aug 14, 2015 · Terminated
  SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.