Tornier Perform® Anatomic Augmented Glenoid DWK503RA15Recalls & reported problems
Tornier, Inc. · Keeled Glenoid Augment · Class 2 · Implant
Data updated Oct 18, 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 00846832090587), received between May 12, 2026 and May 12, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
- Osseointegration Problem1
Patient problems
- Discomfort1
- Inadequate Osseointegration1
- Muscle/Tendon Damage1
- Radiolucent Lines1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2026Off-Label Use; Osseointegration Problem
IT WAS REPORTED THAT, THE PATIENT UNDERWENT A RIGHT PRIMARY ANATOMIC SHOULDER REPLACEMENT ON (B)(6) 2024. ADVISED BY SURGEON YESTERDAY THAT THE PATIENT NOW REQUIRES A REVISION (REMOVAL OF ALL IMPLANTS), AND CONVERSION TO A REVERSE SHOULDER REPLACEMENT, AS THE PATIENT'S ROTATOR CUFF HAS FAILED. THE SURGERY WAS SCHEDULED FOR (B)(6) 2026. RIGHT PRIMARY SHOULDER ARTHROPLASTY ON (B)(6) 2024. PATIENT HAD BEEN COMPLAINING OF DISCOMFORT IN PROSTHETIC RIGHT SHOULDER JOINT APPROX 6 MONTHS POST-OP. X-RAY AT THIS TIME SHOWED SOME EVIDENCE OF LUCENCY AROUND GLENOID COMPONENT. CT SCAN AT 12 MONTHS POST-OP SHOWED INCREASING LUCENCY. HE COMPLAINED OF MORE DISCOMFORT. CT SCAN LATE 2025 SHOWED LOOSE GLENOID COMPONENT, REVISION SURGERY BOOKED. SIMPLICITI HEAD REMOVED, SIMPLICITI NUCLEUS WAS SOLID, BUT THE REVISION TOOLS GOT IT OUT QUITE CLEAN. MINIMAL BONE LOSS. GLENOID PERFORM PLUS POLY WAS VERY LOOSE, CAVITY BEHIND IT. COMPONENT HAD MINIMAL CEMENT STILL ADHERED TO IT. MULTIPLE TISSUE SAMPLES TAKEN, THOUGH SURGEON STATED THAT THERE WERE NO CLINICAL SIGNS OF INFECTION. COPIOUS LAVAGE. SHOULDER JOINT REDUCED, STABLE THROUGH FULL RANGE OF MOTION. EXPLANTED PROSTHESIS BEING RETURNED (IN A STERI-PEEL PKT
Patient problems: Discomfort; Inadequate Osseointegration; Muscle/Tendon Damage; Radiolucent Lines
MAUDE report 25152859 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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