TORNIER PYROCARBON HUM HEAD DIA 50MMX16MMX1.5MM ECC
Report
- Report Number
- 3000931034-2025-00314
- Event Type
- Injury
- Date Received
- June 13, 2025
- Date of Event
- May 14, 2025
- Report Date
- September 9, 2025
- Manufacturer
- TORNIER S.A.S.
- Product Code
- QKW
- UDI-DI
- 03700386943331
- PMA / PMN Number
- DEN220012
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED. SINCE X-RAYS WERE PROVIDED, THE OPINION OF THE MEDICAL EXPERT WAS SOUGHT AND STATED AS FOLLOWS: UNFORTUNATELY, THE TIMELINE OF THIS CHAIN OF EVENTS IS SOMEWHAT CONFUSION. THE OPERATIVE REPORT OF THE INDEX SURGERY WHEN THE PYCHH WAS PLACED IS DATED (B)(6) 2025. THERE¿S NO DATE-STAMP ON THE X-RAY VISIBLE. THE X-RAYS SHOWS THE WELL-POSITIONED AND WELL-FIXED FLEX STEM, AND THE PYCHH. THE JOINT IS WELL-CENTERED, NO SIGNS OF JOINT SPACE NARROWING. SINCE NO ADDITIONAL MEDICAL/CLINICAL INFORMATION IS AVAILABLE, A ROOT CAUSE FOR THE REASON FOR REVISION SURGERY CANNOT BE DETERMINED. FAILURE OF TOTAL SHOULDER REPLACEMENT OVER TIME IS A KNOWN COMPLICATION. IN CASE OF A REVISION PROCEDURE A MEDICAL OPINION AIMING TO DETERMINE THE ROOT CAUSE OF THE FAILURE IS PART OF THE INTERNAL INVESTIGATION PROCESS. SUFFICIENT (RADIOLOGICAL AND CLINICAL) INFORMATION MUST BE PROVIDED TO ENABLE A MEANINGFUL CLINICAL ASSESSMENT AND TO IDENTIFY POSSIBLE CAUSES OF FAILURE. IN CASES WHERE NO SUCH INFORMATION IS AVAILABLE, THIS ASSESSMENT IS LIMITED. NO CONCLUSIVE STATEMENT CAN BE PROVIDED, BECAUSE KEY CLINICAL INFORMATION (E.G. CLINICAL STATUS, EXACT SYMPTOMS AND RANGE OF MOTION OF THE PATIENT, ASSESSMENT OF THE TREATING PHYSICIAN) IS MISSING. DUE TO THESE LIMITATIONS, I AM UNABLE TO PROVIDE STATEMENTS ABOUT THE PATIENT, THE PROCEDURE, AND/OR THE DEVICE IN RELATION TO CAUSE OF THE FAILURE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.
IT WAS REPORTED THAT, THE REVISION SURGERY WAS PERFORMED ON THE RIGHT SHOULDER FROM HEMIARTHROPLASTY (PYROCARBON HUMERAL HEAD) TO ANATOMIC. THE PYC HEAD (DISCARDED BY SCRUB NURSE) WAS EXPLANTED ON (B)(6) 2025 AND HUMERAL STEM WAS LEFT INSITU. PEGGED GLENOID COMPONENT AND HUMERAL HEAD IMPLANTED DURING REVISION SURGERY.
IT WAS REPORTED THAT, THE REVISION SURGERY WAS PERFORMED ON THE RIGHT SHOULDER FROM HEMIARTHROPLASTY (PYROCARBON HUMERAL HEAD) TO ANATOMIC. THE PYC HEAD (DISCARDED BY SCRUB NURSE) WAS EXPLANTED ON (B)(6) 2025 AND HUMERAL STEM WAS LEFT INSITU. PEGGED GLENOID COMPONENT AND HUMERAL HEAD IMPLANTED DURING REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 636549 | TORNIER PYROCARBON HUM HEAD DIA 50MMX16MMX1.5MM ECC | SHOULDER JOINT HUMERAL (HEMI-SHOULDER) CERAMIC HEAD | QKW | TORNIER S.A.S. | 1159AR | 03700386943331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Required Intervention |