SMR System 1322.09.480Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390274258), received between Jan 26, 2026 and May 27, 2026 — classified as 3 injuries.

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 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.

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

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO CONTINUOUS PAIN. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025 TO REMOVE FAILED DJO GLENOID COMPONENTS RE-ESTABLISH SHOULDER FUNCTIONALITY WITH A HEMIARTHROPLASTY CONSISTING OF: HUMERAL BODY REVERSE (PN 1352.15.010, LOT 2509312, STERILIZATION (B)(4) ADAPTOR 36MM FOR REVERSE BODY (PN 1352.15.200, LOT 2307639, STERILIZATION (B)(4) HUMERAL HEAD DIA 48MM (PN 1322.09.480, LOT 2410912, STERILIZATION (B)(4). ORIGINAL STEM WAS LEFT IN PLACE. DUE TO CONTINUOS PAIN AND SEVERE BONE DEFICIENCY OF PATIENT ANTERIOR GLENOID (TEMPORARY PACKED WITH BONE GRAFT DURING PREVIOUS SURGERY), CUSTOM MADE IMPLANT (CMD 26-1040) HAS BEEN REQUESTED FOR AN AUGMENTED GLENOID REVERSE CONFIGURATION WITH CORACOID SUPPORT. REVISION SURGERY TO FINALLY IMPLANT THE CUSTOM MADE DEVICE HAS BEEN SUCCESSFULLY COMPLETED ON (B)(6) 2026 (HEREBY REPORTED): ABOVE MENTIONED HUMERAL COMPOENTS HAVE BEEN REMOVED AND REPLACED WITH NEW HUMERAL BODY REVERSE SHORT (PN 1352.15.005) AND REVERSE LINER +3MM (PN 1360.50.815), WHILE ON THE GLENOID SIDE THE CUSTOM MONOBLOCK GLENOID (PN 9618.14.20M - CMD 26-1040) WITH DJO GLENOSPHERE (RSP GLENOID HEAD 36MM +2MM LATERAL OFFSET) HAVE BEEN PROP

  Patient problems: Implant Pain

  MAUDE report 25297979 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 TO CONVERT AN ANATOMIC CONFIGURATION INTO A REVERSE DUE TO ROTATOR CUFF FAILURE. ORIGINAL SURGERY OCCURRED ON (B)(6) 2025. DURING THE REVISION, PRE-EXISTING FOLLOWING COMPONENTS: CEMENTED GLENOID 3 PEGS STD (PN 1379,50,010, LOT. 21AT03R, STER. (B)(4), HUMERAL HEAD DIA. 48MM (PN 1322.09.480, LOT. 2436382, STER. (B)(4), ADAPTOR TAPER ECCENTRICAL 2MM (PN 1330.15.272, LOT. 2506202, STER. (B)(4), FINNED STEM DIA. 19MM L. 80MM (PN 1304.15.190, LOT. 2434110, STER. (B)(4), HUMERAL BODY TRAUMA MEDIUM (PN 1350.15.010, LOT. 2504857, STER. (B)(4). HAVE BEEN EXPLANTED AND REPLACED WITH: HUMERAL BODY REVERSE SHORT (PN 1325.15.005); REVERSE LINER RETENTIVE +6MM DIA. 40 MM (PN 1365.50.821); CONNECTOR + SCREW SMALL-R (PN 1374.15.305); GLENOSPHERE DIA. 40MM (PN 1374.09.121); METAL BACK GLENOID SMALL-R (PN 1375.21.005). MINIMAL BONE LOSS FOR THE GLENOID WAS CONFIRMED DURING REVISION THAT WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1958. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 24763588 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO ROTATOR CUFF TEAR. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE INFORMATION OF ORIGINAL PROSTHETIC ASSEMBLY. DURING REVISION THE SURGEON REMOVED THE PRE-EXISTING ASSEMBLY INCLUDING HUMERAL HEAD DIA48MM (PN 1322.09.480) AND CONVERTED THE PROSTHESIS TO A REVERSE CONFIGURATION IMPLANTING A LATERALIZED +4MM CONNECTOR (PN 1374.09.11) AND 36MM GLENOSPHERE (PN 1374.09.111) ON THE GLENOID SIDE, AND REVERSE COMPONENTS FROM A DIFFERENT MANUFACTURER ON THE HUMERAL SIDE. SURGERY WAS COMPLETED AS INTENDED. THE PATIENT IF FEMALE, DATE OF BIRTH (B)(6) 1953. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 24176364 ↗

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.