TORNIER HRS PROXIMAL BODY DIA 15
Report
- Report Number
- 0001649390-2024-00365
- Event Type
- Injury
- Date Received
- August 14, 2024
- Date of Event
- June 1, 2024
- Report Date
- May 9, 2025
- Manufacturer
- TORNIER INC
- Product Code
- KWS
- UDI-DI
- 00846832092734
- PMA / PMN Number
- K181420
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. 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. IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.
BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. 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. IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.
PATIENT: (B)(6)- FLEX REVIVE STUDY ADVERSE EVENT DETAIL: POST-OPERATIVE COMPLICATION: INCREASED PAIN AND STIFFNESS OF RIGHT SHOULDER. PATIENT HAS NO REDNESS OR SWELLING. ABNORMAL LABS (B)(6) 2024: CRP, ESR, CBC( HGB, HCT, RDW) AS WELL AS UNDERLYING DEGENERATIVE DISK DISEASE OF THE CERVICAL SPINE. TREATMENT/MEDICATION: PREDNISONE 5MG FOR 15 DAYS.
PATIENT: (B)(6) - FLEX REVIVE STUDY: ADVERSE EVENT DETAIL: POST-OPERATIVE COMPLICATION: INCREASED PAIN AND STIFFNESS OF RIGHT SHOULDER. PATIENT HAS NO REDNESS OR SWELLING. ABNORMAL LABS (B)(6) 2024: CRP, ESR, CBC( HGB, HCT, RDW) AS WELL AS UNDERLYING DEGENERATIVE DISK DISEASE OF THE CERVICAL SPINE. TREATMENT/MEDICATION: PREDNISONE 5MG FOR 15 DAYS.
PATIENT: (B)(6) - FLEX REVIVE STUDY. ADVERSE EVENT DETAIL: POST-OPERATIVE COMPLICATION: INCREASED PAIN AND STIFFNESS OF RIGHT SHOULDER. PATIENT HAS NO REDNESS OR SWELLING. ABNORMAL LABS (B)(6) 2024: CRP, ESR, CBC (HGB, HCT, RDW) AS WELL AS UNDERLYING DEGENERATIVE DISK DISEASE OF THE CERVICAL SPINE. TREATMENT/MEDICATION: PREDNISONE 5MG FOR 15 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1152850 | TORNIER HRS PROXIMAL BODY DIA 15 | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | KWS | TORNIER INC | AZ4422215 | 00846832092734 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Other| R |