Arthrex® AR-9148-17Recalls & reported problems
Arthrex, Inc. · UNIVERS HUMERAL HEAD 48/17 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867136113), received between Dec 7, 2021 and Dec 7, 2021 — classified as 1 injury.
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
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2021Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2021, IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT EXPERIENCED AN ADVERSE EVENT UNDERGOING A SHOULDER ARTHROPLASTY PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2021: THE DATE OF THE PRIMARY PROCEDURE WAS 09/16/2015 FOR A SHOULDER ARTHROPLASTY. THIS PROCEDURE TOOK PLACE AT SOUTHERN OREGON ORTHOPEDIC, ARTHREX ACCOUNT # (B)(4), ON (B)(6) 2015. A COMPLICATION WAS REPORTED ON 05/25/2021 AND THE DATE OF THE SECONDARY PROCEDURE WAS ON (B)(6) 2021. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2021 : THE DATE OF THE REVISION SURGERY WAS ON (B)(6) 2021. THE PATIENT HAD PAIN THAT BEGAN ABOUT FIVE AND A HALF YEARS POST OPERATIVE, AND CONTINUED TO INCREASE AFFECTING THE QOL AND THEREFOR LEADING TO THIS REVISION. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2021 THE FOLLOWING EXPLANTED DEVICE NUMBERS WERE PROVIDED AR-9100-10S, LOT#1349768, AR-9105-02, LOT #1503005, AR-9148-17 LOT #2501448207.
Patient problems: Pain
MAUDE report 12954047 ↗
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- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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