DLT TS CER HD 12/14 32MM +9
Report
- Report Number
- 1818910-2023-24690
- Event Type
- Injury
- Date Received
- December 6, 2023
- Date of Event
- November 28, 2023
- Report Date
- December 6, 2023
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- KWA
- UDI-DI
- 10603295033486
- PMA / PMN Number
- K073570
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿PATIENT HAS BEEN COMPLAINING OF A "CLUNKING" HIP REPLACEMENT AFTER 2 YEARS POST-OP. THERE HAS ALREADY BEEN A REVISION CHANGE OF HEAD TO THE FEMORAL STEM TO COUNTERACT THE ISSUE, BUT SHE STILL APPEARS TO BE ABLE TO MANUALLY DISLOCATE THE HIP WITH FORCE. SHE HAS COME BACK TODAY FOR REVISION SURGERY AGAIN, THIS TIME TO REMOVE THE CUP AND LINER AND REPLACE WITH NEW COMPONENTS. UPON OPEN THE HIP JOINT THERE WERE FRAGMENTS OF CERAMIC IN THE WOUND, THIS APPEARED TO BE FROM THE CERAMIC LINER AS THE HEAD LOOKS IN PRISTINE CONDITION. ONCE CUP WAS REMOVED IT APPEARS THERE IS A SECTION OF THE CERAMIC LINER THAT HAS FRACTURED OFF, THIS IS IN LINE WITH THE FRAGMENTS FOUND IN THE WOUND. THE SURGEON STATES THAT IT IS VERY HARD TO MANUALLY REPRODUCE THE DISLOCATION THE PATIENT IS EXPERIENCING, BUT THE PATIENT USES THIS AS A "PARTY TRICK" TO SHOW THE CLUNKING TO PEOPLE. THE HEAD AND LINER BOTH SHOW SIGNS OF METAL WEAR AGAINST COMPONENTS IN KEEPING WITH THE NARRATIVE OF BEING ABLE TO DISLOCATE AT WILL. A NEW HEAD, LINER AND CUP WERE REPLACED AS EXPECTED AND I WILL FOLLOW-UP IN COMING MONTHS TO SEE IF THE SAME PROBLEM PERSISTS AFTER THIS SURGERY¿. THE PRODUCT AND PHOTOS (MG_0824.JPG) WERE RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE ALONG WITH A MANUFACTURING INVESTIGATION PERFORMED BY SUPPLIER. FURTHER DETAILS OF THE DEVICE'S ANALYSIS WERE ATTACHED ON "240426 FINAL REPORT KIV 24 01 27_RP.PDF". VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT DLT TS CER HD 12/14 32MM +9 PRESENTS METAL TRANSFER OF ERRATIC APPEARANCE ON THE OUTER SURFACE AND FACE OF THE CERAMIC HEAD, MOST LIKELY CAUSED BY CHAFING BETWEEN METAL PARTS AND BROKEN CERAMIC FRAGMENTS AFTER THE PRIMARY FRACTURE EVENT OF THE LINER AND DURING SURGICAL PROCEDURES. ADDITIONALLY, THIN CONCENTRIC LINES OVER THE WHOLE CIRCUMFERENCE OF THE TOP SECTION OF THE TAPER WAS NOT OBSERVED SINCE THE METAL SLEEVE IS CURRENTLY FIXATED IN THE FEMORAL HEAD. THEREFORE, THE PRIMARY METAL TRANSFER THAT SUGGEST A SYMMETRICAL TAPER FIT BETWEEN THE CERAMIC HEAD AND SLEEVE CANNOT BE EVALUATED. SMEARED METAL TRANSFER WAS ALSO FOUND ON THE INNER SECTION OF THE LINER AND POLISHED SURFACE OF THE FEMORAL HEAD. THESE METAL TRANSFER PATTERNS COULD HAVE BEEN CAUSED BY SMALL METAL PARTICLES GETTING INTO THE BEARING; SUCH SMALL PARTICLES COULD HAVE BEEN CREATED BY IMPINGEMENT BETWEEN THE METAL STEM AND THE CERAMIC LINER. ON THE POLISHED SURFACE OF THE FEMORAL HEAD, AN AREA OF ABRASION AND SMALL BREAKOUT WAS FOUND. THE OCCURRENCE OF THIS METAL TRANSFER AND BREAKOUTS IS A CONSEQUENCE OF RECURRING CONTACTS WITH THE METAL CUP AND FRAGMENTS OF THE LINER AFTER THE PRIMARY FRACTURE EVENT. SIGNS OF INCREASED WEAR WERE ALSO FOUND ON THE POLISHED SURFACE. HOWEVER, IT CANNOT BE DETERMINED WHETHER THESE AREAS WERE GENERATED BY MICROSEPARATION / EDGE LOADING PRIOR TO THE FRACTURE OR CAUSED BY CERAMIC FRAGMENTS AND THIRD-BODY WEAR AFTER THE PRIMARY FRACTURE EVENT. BASED ON THE OBSERVED CONDITION FOR THE DEVICE, IT IS NOT UNREASONABLE THAT NOISE WOULD BE PRESENT DUE TO CHAFING WITH THE BROKEN LINER FRAGMENT AND AN UNINTENTIONAL CONTACT WITH THE EDGE OF THE ACETABULAR CUP. WITH THE INFORMATION PROVIDED IS NOT POSSIBLE TO DETERMINE A POTENTIAL CAUSE AT THIS MOMENT. HOWEVER, IN SUPPORT OF THE EVALUATION PERFORMED, THE OBSERVED DAMAGE OF THE FEMORAL HEAD MAY HAVE BEEN CAUSED BY THE FACT THAT THE PATIENT USED A FORCED DISLOCATION AS A "PARTY TRICK". CONSIDERATION MUST BE GIVEN TO ALL POTENTIAL INFLUENCES SUCH AS SURGICAL PROCESS, PATIENT VARIABLES (E.G. ACTIVITY LEVEL AND USE), ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. IT IS HIGHLY RECOMMENDED TO THE PATIENT TO CONSULT WITH THEIR HEALTHCARE PROFESSIONAL FOR FURTHER ASSESSMENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136532730 / 9226584] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE -EXISTING MATERIAL DEFECT. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DLT TS CER HD 12/14 32MM +9 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. 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 REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES 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: PROTOCOLS AND ACCEPTANCE CERTIFICATE WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE DATA OBTAINED ON THE FEMORAL HEAD CONFORMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE -EXISTING MATERIAL DEFECT. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136532730 / 9226584] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING.
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 THAT 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. 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). 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 THAT 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. H10 ADDITIONAL NARRATIVE: ADDED: B5 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). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE LEFT HIP.
PATIENT HAS BEEN COMPLAINING OF A "CLUNKING" HIP REPLACEMENT AFTER 2 YEARS POST-OP. THERE HAS ALREADY BEEN A REVISION CHANGE OF HEAD TO THE FEMORAL STEM TO COUNTERACT THE ISSUE, BUT SHE STILL APPEARS TO BE ABLE TO MANUALLY DISLOCATE THE HIP WITH FORCE. SHE HAS COME BACK TODAY FOR REVISION SURGERY AGAIN, THIS TIME TO REMOVE THE CUP AND LINER AND REPLACE WITH NEW COMPONENTS. UPON OPEN THE HIP JOINT THERE WERE FRAGMENTS OF CERAMIC IN THE WOUND, THIS APPEARED TO BE FROM THE CERAMIC LINER AS THE HEAD LOOKS IN PRISTINE CONDITION. ONCE CUP WAS REMOVED IT APPEARS THERE IS A SECTION OF THE CERAMIC LINER THAT HAS FRACTURED OFF, THIS IS IN LINE WITH THE FRAGMENTS FOUND IN THE WOUND. THE SURGEON STATES THAT IT IS VERY HARD TO MANUALLY REPRODUCE THE DISLOCATION THE PATIENT IS EXPERIENCING. THE HEAD AND LINER BOTH SHOW SIGNS OF METAL WEAR AGAINST COMPONENTS IN KEEPING WITH THE NARRATIVE OF BEING ABLE TO DISLOCATE AT WILL. A NEW HEAD, LINER AND CUP WERE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1941189 | DLT TS CER HD 12/14 32MM +9 | ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS | KWA | DEPUY ORTHOPAEDICS INC US | 9226584 | 10603295033486 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Female | Required Intervention | DELTA CER INSERT 32ID X 48OD| PINN SECTOR W/GRIPTION 48MM |