UNKNOWN TORNIER PYROCARBON HUMERAL HEAD
Received May 8, 2026 · Event occurred Jun 1, 2022
Report 3000931034-2026-00402 · MDR key 25120948
Device
Generic name
Shoulder Joint Humeral (hemi-shoulder) Ceramic Head/metallic Stem Cemented Or Un
Manufacturer
Tornier S.a.s.Catalog number
UNK_WTM
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
53 YR · Male
- Wound Dehiscence
Narrative
Additional Manufacturer Narrative
THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.
Description of Event or Problem
THE MANUFACTURER RECEIVED SCS STUDY NAMED "A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF SHOULDER JOINT REPLACEMENT WITH THE AEQUALIS PYROCARBOM HUMERAL HEAD" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PYROCARBON HUMERAL HEAD. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2016 ¿ JUNE 2022. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: CASE NUMBER SIX WAS A 53-YEAR-OLD MALE WHO HAD HEMIARTHROPLASTY FOR RIGHT AVASCULAR NECROSIS AND DESCRIBED WOUND ISSUES AT TWO MONTHS WHICH RESOLVED SATISFACTORILY WITH NO FURTHER SURGICAL INPUT. THE CLINICAL OUTCOME AND PATIENT SATISFACTION WAS IN LINE WITH THE STAGE OF RECOVERY. THE PATIENT DID NOT UNDERGO A RE-OPERATION OR REVISION.