TC3 RP TIBIAL INSERT S5,20.0
Report
- Report Number
- 1818910-2024-25690
- Event Type
- Injury
- Date Received
- December 19, 2024
- Date of Event
- January 1, 2016
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- NJL
- UDI-DI
- 10603295242543
- PMA / PMN Number
- P830055
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES HAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: A1, A2 (DOB), A3A (SEX), B5, B7, D4 (LOT, EXPIRATION DATE), D6B, D10, G4, H4 AND H6 (HEALTH EFFECT - CLINICAL CODE). CORRECTED: D1, D2A, D2B, D4 (CATALOG, UDI). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (B)(4) GTIN IS NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: PATIENT STATES HE HAD KNEE REPLACEMENT AROUND 2004, HAD REVISION DONE IN 2016 IN (B)(6) BY SURGEON AT A HOSPITAL. HE CONTINUED TO HAVE ISSUES AND IN (B)(6) 2023 WENT TO ANOTHER SURGEON IN ANOTHER HOSPITAL WHO REPLACED WHAT HE CONSIDERED DAMAGED COMPONENTS. HE HAS SPOKEN WITH ATTORNEY. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS AND A VIDEO WERE PROVIDED FOR REVIEW. (B)(4) DEVICE VIDEO AD (B)(6) 2024, (B)(4) DEVICE PHOTO AD (B)(6) 2024 (1), (B)(4) DEVICE PHOTO AD (B)(6) 2024 (2), (B)(4) EXTERNAL KNEE REVISION (2.53 MB). THE PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER THEY DO NOT REPRESENT THE REPORTED PRODUCT. THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED PRODUCT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED PRODUCT COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> PATIENT STATES HE HAD KNEE REPLACEMENT AROUND 2004, HAD REVISION DONE IN 2016 IN (B)(6) AT A HOSPITAL. HE CONTINUED TO HAVE ISSUES AND IN (B)(6) 2023 WENT TO ANOTHER SURGEON IN ANOTHER HOSPITAL WHO REPLACED WHAT HE CONSIDERED DAMAGED COMPONENTS. HE HAS SPOKEN WITH ATTORNEY. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS AND A VIDEO WERE PROVIDED FOR REVIEW. SEE ATTACHMENT (B)(4) DEVICE VIDEO AD 31 JUL 2024, (B)(4) DEVICE PHOTO AD 31 JUL 2024 (1), (B)(4) DEVICE PHOTO AD 31 JUL 2024 (2), (B)(4) EXTERNAL KNEE REVISION (2.53 MB). THE PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER THEY DO NOT REPRESENT THE REPORTED PRODUCT. THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED PRODUCT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 962365 LOT NUMBER: 706919, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED PRODUCT COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 962365 LOT NUMBER: 706919, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.
MEDICAL RECORDS RECEIVED. DOI: (B)(6) 2016: 65-YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION OF UNKNOWN IMPLANTS TO TREAT TIBIAL TRAY LOOSENING, METALLOSIS, AND OSTEOLYSIS. THE IMPLANTS REVISED IN THIS PROCEDURE ARE UNKNOWN AND WILL NOT BE CAPTURED AS A COMPLAINT. THE PATIENT RECEIVED A TC3 REVISION KNEE, DEPUY RESURFACED PATELLA, AND DEPUY CEMENT X 4. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2023: 73- YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PROGRESSIVE PAIN, SWELLING, WALKING DIFFICULTY, AND STIFFNESS. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED METALLOSIS AND SYNOVITIS. THE SURGEON DETERMINED THE CAUSE OF THE METALLOSIS WAS THE DISASSOCIATION OF THE FEMORAL ADAPTOR AND ADAPTOR BOLT, CAUSING MOVEMENT AT THE ADAPTOR AND BOLT JUNCTION. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED FEMORAL COMPONENT. THE FEMORAL SLEEVE AND STEM WERE WELL-FIXED AND RETAINED. THE PATELLA WAS LOOSENED AT AN UNKNOWN INTERFACE SECONDARY TO PATELLAR OSTEOLYSIS AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE TIBIAL TRAY, SLEEVE, AND STEM WERE WELL-FIXED AND RETAINED. THERE WAS SOME MEDIAL TIBIAL OSTEOLYSIS THAT WAS TREATED WITH IMPACTION BONE GRAFTING. THE PATIENT WAS REVISED WITH COMPETITOR CEMENT AND DEPUY TC3 IMPLANTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016. DOR (B)(6) 2023. RIGHT KNEE.
IT WAS REPORTED THAT THE PATIENT HAD HIS KNEE REPLACED IN 2004. ON (B)(4) 2016 PATIENT HAD POST-OPERATIVE X-RAYS OF THE RIGHT TOTAL KNEE REPLACEMENT. THE APPEARANCE WAS FOR A NORMAL APPEARANCE NEW RIGHT TOTAL KNEE. X-RAYS OF THE RIGHT TOTAL HIP ARTHROPLASTY (MANUFACTURER UNIDENTIFIED) WERE UNREMARKABLE--NO LOOSENING, FRACTURES, OR DISLOCATION OBSERVED. DISCHARGE SUMMARY FOR (B)(4) 2016 INDICATED PATIENT HAD ACHIEVED ALL OF HIS MILESTONES FOR REVISION KNEE POST-OP DAYS 1 THRU 3 AND WOULD BE DISCHARGED WITH HOME PHYSICAL THERAPY FOR TREATMENT OF A STABLE COMPLETE REVISION OF THE RIGHT TOTAL KNEE. PRE-OPERATIVE HISTORY AND PHYSICAL FOR RIGHT KNEE ARTHROPLASTY REVISION, TO ADDRESS PAIN, SOME MEDIAL INSERT WEAR, AND OSTEOLYSIS OF THE PROXIMAL TIBIA, WITH NO EVIDENCE OF INFECTION OR RADIOGRAPHIC IMPLANT LOOSENING. REVISION OPERATIVE NOTE INDICATED THAT PATIENT'S 19-YEAR-OLD RIGHT TOTAL KNEE REPLACEMENT WAS REVISED ON (B)(4) 2016, TO ADDRESS TIBIAL PAIN AND OSTEOLYSIS. INTRAOPERATIVELY, THE SURGEON IDENTIFIED UPON ENTERING THE JOINT THAT THERE WAS METAL-STAINED TISSUES (METALLOSIS). THE DEPUY METAL-BACKED PATELLA COMPONENT DEMONSTRATED SOME POLYETHYLENE WEAR, SO THE POLYETHYLENE PART OF THE PATELLA WAS REMOVED AND REVISED WITH A NEW DEPUY POLYETHYLENE COMPONENT, WHILE PRESERVING THE WELL-FIXED METAL BACKING. THE TIBIAL TRAY COMPONENT WAS FOUND TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE, WITH NO CEMENT RETAINED ON THE TIBIAL TRAY COMPONENT WHEN REMOVED. THE FEMUR COMPONENT WAS WELL-FIXED BUT SHOWED SOME EVIDENCE OF BURNISHING OF THE METAL FEMUR COMPONENT, FOR WHICH THE CAUSE WAS NOT KNOWN. SIGNIFICANT FEMORAL OSTEOLYSIS WAS OBSERVED BENEATH THE FEMUR COMPONENT, AND SO THE FEMUR WAS EXPLANTED AS WELL, DESPITE NOT BEING LOOSE. DURING REMOVAL OF THE TIBIA AND FEMUR COMPONENTS, THE SURGEON DEBRIDED A LOT OF METAL-STAINED SOFT TISSUES AND OSTEOLYSIS. FEMUR AND TIBIA WERE REPLACED WITH DEPUY TC3 FEMORAL SLEEVE AND STEM CONSTRUCTS (CEMENT ON THE FEMUR AND TIBIA, BUT INGROWTH FOR STEM AND SLEEVES FOR BOTH, USING DEPUY GENTAMYCIN CEMENT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2098099 | TC3 RP TIBIAL INSERT S5,20.0 | SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT | NJL | DEPUY ORTHOPAEDICS INC US | 706919 | 10603295242543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Required Intervention | LCS CRUC M/B PAT REPLC GVF LG+| MBT REVISION CEM TIB TRAY SZ 5| PFC*SIGMA TC3 FEM RT SZ5| SIG FEM ADAP +2/-2 OFFSET BOLT| SIGMA FEM ADAPTER 5 DEGREE| SMARTSET GHV GENTAMICIN 40G| SMARTSET GHV GENTAMICIN 40G| SMARTSET GHV GENTAMICIN 40G| SMARTSET GHV GENTAMICIN 40G |