FDA Adverse Event
Injury
Summary report: N
PHYSICA KR
MDR report key: 21148461
·
Received January 14, 2025
Report
- Report Number
- 3008021110-2024-00112
- Event Type
- Injury
- Date Received
- January 14, 2025
- Date of Event
- September 12, 2024
- Report Date
- January 9, 2025
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- HRY
- UDI-DI
- 08033390089517
- PMA / PMN Number
- K141934
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED PART CODES, NO PRE-EXISTING ANOMALY WAS DISCOVERED ON THE ITEMS BELONGING TO THE SAME LOT NUMBERS. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 0
REVISION SURGERY DUE TO PAIN AND LOOSENING OF IMPLANT, PERFORMED ON (B)(6) 2024. THE COMPONENTS REMOVED WERE THE FOLLOWING: PHYSICA KR FEMUR COMP. LEFT #7 (PART CODE (B)(6), LOT NUMBER 17AS01W, STERILIZATION (B)(6)). PHYSICA FIXED TIBIAL PLATE #7 (PART CODE (B)(6), LOT NUMBER 1800879, STERILIZATION (B)(6)). PHYSICA KR TIB. LINER LEFT #7 (PART CODE (B)(6), LOT 15AT0GG, STERILIZATION (B)(6)). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2018. THE PATIENT IS A MALE, 60 YEARS OLD. THE EVENT HAPPENED IN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1486812 | PHYSICA KR | KR LINER LEFT #7 - H. 10 | HRY | LIMACORPORATE S.P.A. | 6532.50.710 | 15AT0GG | 08033390089517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |