PHYSICA FIXED TIBIAL PLATE #9
Report
- Report Number
- 3008021110-2023-00023
- Event Type
- Injury
- Date Received
- March 7, 2023
- Date of Event
- November 7, 2022
- Report Date
- April 17, 2024
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- JWH
- PMA / PMN Number
- K141934
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBER, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS WITH LOT NR. 2006869. THEREFORE, WE CAN STATE THAT THEY WERE MANUFACTURED UP TO DRAWING SPECIFICATIONS AND IN LINE WITH THE RELEVANT CHECKS AND TESTS. ACCORDING TO OUR RECORDS, AT LEAST 18 OUT 23 OF PHYSICA TIBIAL PLATES WITH LOT NR. 2006869 - STER. 2000258 HAVE BEEN IMPLANTED, AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. THE EXPLANTED COMPONENTS WERE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS AND ACCORDING TO THE VISUAL INSPECTIONS NO ANOMALIES WERE DETECTED ON THE EXPLANTS. THE FOLLOWING X-RAYS WERE RECEIVED AND ANALYZED BY A MEDICAL EXPERT, TOGETHER WITH THE AVAILABLE OPERATIVE NOTES PROVIDED BY THE COMPLAINT SOURCE: - (B)(6) 2022 (PRE - OP PRIMARY SURGERY); - (B)(6) 2022 (POST - OP PRIMARY SURGERY); - (B)(6) 2022 (THREE MONTHS POST- OP PRIMARY SURGERY); - (B)(6) 2022 (POST - OP REVISION SURGERY); - (B)(6) 2022 (POST - OP REVISION SURGERY); - (B)(6) 2022 (POST - OP REVISION SURGERY). WITH REFERENCE TO THE PRIMARY SURGERY ((B)(6), 2022) THE MEDICAL EXPERT CONCLUDED THE FOLLOWING: - PREOPERATIVE X-RAYS (DATED (B)(6), 2022): MECHANICAL ALIGNMENT OF THE LEG IS MILD VARUS, THERE IS SEVERE GONARTHROSIS AT THE MEDIAL COMPARTMENT, BUT MILD AT THE FIBULAR COMPARTMENT. - POSTOPERATIVE X-RAYS (DATED (B)(6) 2022): FEMORAL COMPONENT - GOOD SIZING OF FEMORAL COMPONENT IN AP AND LATERAL VIEW, CORRECT ROTATION IN SKYLINE VIEW AND CORRECT PATELLAR TRACKING, DMFA IS 93°, ON THE LATERAL VIEW THERE IS APPROX. 4,5° OF FLEXION. TIBIAL COMPONENT - MORE IN ROTATION, POSSIBLE EXTERNAL ROTATION, MILD OVERHANG ON THE MEDIAL SIDE AND POSTERIORLY ON THE FIBULAR SIDE, POSTERIOR SLOPE OF 5°, AS WELL AS MEDIAL INCLINATION OF 5°. NO EVIDENCE OF RADIOLUCENT LINES. - POSTOPERATIVE X-RAYS (DATED (B)(6), 2022): THERE IS INCREASED MEDIAL INCLINATION AS WELL AS THE POSTERIOR SLOPE AND SEPARATION ON THE INTERFACE BONE CEMENT-BONE. THERE IS EXTERNED ROTATION OF THE TIBIAL COMPONENT. POSSIBLE RADIOLUCENT LINE AROUND THE STEM-GREEN ARROWS WHICH COULD INDICATE MACRO-MOTION. WITH REFERENCE TO THE REVISION SURGERY ((B)(6) 2022) THE MEDICAL EXPERT CONCLUDED THE FOLLOWING: - POSTOPERATIVE X-RAY (DATED (B)(6) 2022): AFTER REVISION SURGERY CONFIRMING RESTORING OF THE MECHANICAL ALIGNMENT OF THE LEG WITH VALGUS ANGLE OF THE JOINT LINE OF 7,0 DEGREES OF VALGUS. IMPLANT USED IS WITH THE LONG STEMS WITH NO SIGNS OF THE CEMENT MANTLE WITH PROBABLY INCREASED ML STABILITY. GOOD BONE CONTACT ON THE INTERFACE BONE CEMENT/ BONE ON PROXIMAL TIBIA SIDE. CONSIDERING THAT: · CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOT NUMBER 2006869. · THE VISUAL INSPECTION OF THE EXPLANTS DID NOT HIGHLIGHT ANY ANOMALIES. · AND ACCORDING TO THE MEDICAL EXPERT CONCLUSION OF THE EVALUATION ON THE X-RAYS: "AFTER THE PRIMARY TKA ON (B)(6) 2022. TIBIAL COMPONENT - MORE IN ROTATION, POSSIBLE EXTERNAL ROTATION, MILD OVERHANG ON THE MEDIAL SIDE AND POSTERIORLY ON THE FIBULAR SIDE, POSTERIOR SLOPE OF 5°, AS WELL AS MEDIAL INCLINATION OF 5°. NO EVIDENCE OF RADIOLUCENT LINES WITH FEMORAL COMPONENTS ON THE LATERAL VIEW: APPROX. 4,5° OF FLEXION AND ML CORRECT SIZING. AFTER THREE MONTHS INCREASED MEDIAL INCLINATION TO 6,0° AND AS WELL POSTERIOR SLOPE TO. 6,5°. EVIDENCE OF SEPARATION ON THE BONE CEMENT/BONE INTERFACE ON THE TIBIAL COMPONENT, NO LOOSENING OF THE FEMORAL ONE. THE PAINFUL TKA COULD BE EXPLAINED DUE TO THE MILD OVER SIZING, EXTERNAL ROTATION AND POOR CEMENTING TECHNIQUE ON THE TIBIAL COMPONENT. NO RADIOLOGICAL AND CLINICAL EVIDENCE OF SEPTIC LOOSENING.". WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT. STILL, BASED ON ABOVE FINDINGS, WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF PHYSICA FIXED TIBIAL PLATE (FAMILY CODE: 6522.15.XXX) 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. THIS IS AN MDR FINAL REPORT-
BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 23 TIBIAL PLATES RELEASED WITH LOT NUMBER 2006869. THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THIS LOT NUMBER (2006869). WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION WILL BE COMPLETED.
KNEE REVISION SURGERY DUE TO LOOSENING OF THE PHYSICA FIXED TIBIAL PLATE #9 (PRODUCT CODE 6522.15.090, LOT 2006869, STER. 2000258). THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: · PHYSICA PS FEMUR COMP.RIGHT #8 (PRODUCT CODE: 6515.09.180, LOT NR. 22AS030 - STER. 2200046); · PHYSICA FIXED TIBIAL PLATE #9 (PRODUCT CODE: 6522.15.090, LOT NR. 2006869 - STER. 2000258); · PHYSICA PS TIBIAL LINER #9 (PRODUCT CODE: 6535.50.910, LOT NR. 21AT16Z - STER. 2100352); · PHYSICA TIBIAL STEM L.20MM (PRODUCT CODE: 6590.15.020, LOT NR. 2200101 - STER. 2200079). THE DATE OF THE REVISION SURGERY IS NOVEMBER 7TH, 2022, THE PREVIOUS SURGERY OCCURRED ON MAY 18TH, 2022. IN THE LAST FEW MONTHS, THE PATIENT HAS BEEN COMPLAINING OF SEVERE KNEE PROBLEMS AND VERY SEVERE PAIN DURING EXERCISE. NATIVE RADIOLOGICAL EVIDENCE OF LOOSENING OF THE TIBIAL PLATEAU. AFTER THE KNEE JOINT PUNCTURE AND DETAILED DISCUSSION WITH THE PATIENT, WE DECIDED TO REPLACE THE KNEE ENDOPROTHESIS DUE TO THE ASEPTIC LOOSENING. PATIENT IS A MALE, 72 YEARS OLD. IT WAS REPORTED HE WEIGHTED 130 (KG) AT THE TIME OF THE PREVIOUS SURGERY AND HE'S HEIGH WAS 182 (CM). THE PATIENT SUFFERS FROM ADIPOSITAS, INDICATED AS RELEVANT CLINCAL INFORMATION. EVENT OCCURRED IN GERMANY.
KNEE REVISION SURGERY DUE TO LOOSENING OF THE PHYSICA FIXED TIBIAL PLATE #9 (PRODUCT CODE 6522.15.090, LOT 2006869, STER. 2000258). THE DATE OF THE REVISION SURGERY IS NOT KNOWN, THE PREVIOUS SURGERY OCCURRED ON (B)(6), 2022. PATIENT DATA: MALE, 72 YEARS OLD, 182 CM, 130 KG. THIS EVENT OCCURRED IN GERMANY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85470 | PHYSICA FIXED TIBIAL PLATE #9 | PHYSICA FIXED TIBIAL PLATE #9, | JWH | LIMACORPORATE S.P.A. | 6522.15.090 | 2006869 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |