PHYSICA KR TIB. LINER RIGHT #7
Report
- Report Number
- 3008021110-2022-00127
- Event Type
- Injury
- Date Received
- December 19, 2022
- Date of Event
- March 30, 2022
- Report Date
- September 21, 2023
- Manufacturer
- LIMACORPORATE S.P.A
- Product Code
- MBH
- PMA / PMN Number
- K201084
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BY THE CHECK OF WO, NO MANUFACTURING ANOMALIES ON BOTH LOT NUMBERS REFERRING TO PHYSICA TT TIBIAL TRAY (B)(4) AND TO PHYSICA KR TIBIAL LINER (B)(4). WE WILL SEND A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.
BY THE CHECK OF WO, NO MANUFACTURING ANOMALIES ON BOTH LOT NUMBERS REFERRING TO PHYSICA TT TIBIAL TRAY ((B)(6)) AND TO PHYSICA KR TIBIAL LINER ((B)(6)). THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY NO PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE ACCESSIBLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT: · THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S, · ACCORDING TO THE INFORMATION REPORTED, EVENT WAS RELATED TO POOR BONE QUALITY. WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE FOR PHYSICA KR PROTHESIS DUE TO LOOSENING IS (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS FINAL MDR.
KNEE REVISION SURGERY PERFORMED ON (B)(6) 2022 DUE TO LOOSENING. ACCORDING TO THE COMPLAINT SOURCE, DURING THE PREVIOUS SURGERY PERFORMED ON (B)(6) 2022, THE SURGEON IMPLANTED A PHYSICA TT TIBIAL TRAY #7, PRODUCT CODE 6521.14.070, LOT 2122982, STER. (B)(4) AND A PHYSICA KR TIBIAL LINER #7, PRODUCT CODE 6531.54.716, LOT 2021286, STER (B)(4). SUBSEQUENTLY, PATIENT ANATOMY FAILED AND THE SURGEON CHOSE TO CONVERT THE IMPLANT TO A CEMENTED PHYSICA KR SYSTEM. ACCORDING TO THE INFORMATION REPORTED, EVENT WAS RELATED TO POOR BONE QUALITY. AS ADDITIONAL COMMENTS, IT WAS REPORTED THAT SURGEON WAS SATISFIED WITH INITIAL SURGERY BUT WHEN THE LOOSENING WAS EXPERIENCED, SURGEON COMMENTED THAT SHOULD HAVE GONE WITH A CEMENTED TIBIAL IMPLANT SINCE THE BEGINNING. EVENT HAPPENED IN US.
KNEE REVISION SURGERY PERFORMED ON (B)(6) 2022 DUE TO LOOSENING. ACCORDING TO THE COMPLAINT SOURCE, DURING THE PREVIOUS SURGERY PERFORMED ON (B)(6) 2022, THE SURGEON IMPLANTED A PHYSICA TT TIBIAL TRAY #7, PRODUCT CODE 6521.14.070, LOT 2122982, STER. (B)(4) AND A PHYSICA KR TIBIAL LINER #7, PRODUCT CODE 6531.54.716, LOT 2021286, STER (B)(4). SUBSEQUENTLY, PATIENT ANATOMY FAILED AND THE SURGEON CHOSE TO CONVERT THE IMPLANT TO A CEMENTED PHYSICA KR SYSTEM. ACCORDING TO THE INFORMATION REPORTED, EVENT WAS RELATED TO POOR BONE QUALITY. AS ADDITIONAL COMMENTS, IT WAS REPORTED THAT SURGEON WAS SATISFIED WITH INITIAL SURGERY BUT WHEN THE LOOSENING WAS EXPERIENCED, SURGEON COMMENTED THAT SHOULD HAVE GONE WITH A CEMENTED TIBIAL IMPLANT SINCE THE BEGINNING. PATIENT - FEMALE. DATE OF BIRTH - (B)(6). EVENT HAPPENED IN US.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2700361 | PHYSICA KR TIB. LINER RIGHT #7 | PHYSICA KR LINERS (CROSS-LINKED UHMWPE WITH VITAMIN E) - RIGHT #7 - H. 16 | MBH | LIMACORPORATE S.P.A | 6531.54.716 | 2021286 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Female | Required Intervention |