Affiniti™ Cortiloc™ 0020063Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832002153), received between Jun 28, 2022 and Jan 27, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Migration1
- Osseointegration Problem1
Patient problems
- Implant Pain1
- Inadequate Osseointegration1
- Loss of Range of Motion1
- Subluxation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2025Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration Problem
IT WAS REPORTED BY THE DOCTOR THAT THE PATIENT HAD A FAILED POSTERIOR CUFF IN THE YEARS FOLLOWING THE INITIAL SURGERY CAUSING POSTERIOR HUMERAL SUBLUXATION. THIS CAUSED THE GLENOID COMPONENT TO LOOSEN OVER TIME AND EVENTUALLY DISLODGE FROM THE GLENOID.
Patient problems: Inadequate Osseointegration; Subluxation
MAUDE report 21242135 ↗InjuryJun 28, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND LOSS OF RANGE OF MOTION. THE CT SCAN SHOWED GLENOID LUCENCY WITH EXTENSIVE LYTIC DESTRUCTION OF THE GLENOID AND COMPONENT LOOSENING. ADVERSE EVENT OUTCOME IS STILL ONGOING, THIS AE IS CURRENTLY UNRESOLVED.
Patient problems: Implant Pain; Loss of Range of Motion
MAUDE report 14842286 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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