Affiniti™ Cortiloc™ 0020062Recalls & 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 00846832002146), received between Jun 25, 2024 and Sep 18, 2024 — 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
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Implant Pain2
- Bacterial Infection1
- Inadequate Osseointegration1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY. INFECTION PAIN AND GLENOID LOOSENING. ROTATOR CUFF INSUFFICIENCY AND INFECTION. RE-OPERATION ON (B)(6) 2021; IMPLANTS REMOVED AND PLACEMENT OF ANTIBIOTIC SPACER, RE-OPERATION ON (B)(6) 2021; REMOVAL OF SPACER, RE-IMPLANTATION OF REVERSE TOTAL SHOULDER.
Patient problems: Bacterial Infection; Implant Pain; Inadequate Osseointegration
MAUDE report 20244134 ↗InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "IMPINGEMENT SYNDROME: PERSISTENT SYMPTOMS LOCALIZED OVER AC JOINT AND ALONG THE SUB ACROMIAL SPACE. ADDITIONAL INFORMATION RECEIVED ON 31 MAY 2024: RE-OPERATION ON (B)(6) 2017 (NO COMPONENT REMOVAL). 1. ARTHROSCOPIC ACROMIOCLAVICULAR JOINT RESECTION. 2. ARTHROSCOPIC SUB ACROMIAL DECOMPRESSION. OTHER ACTION TAKEN: REHABILITATION/PHYSICAL THERAPY. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019."
Patient problems: Implant Pain
MAUDE report 19608190 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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