EA DELTA CER INSERT 36IDX52OD
Report
- Report Number
- 1818910-2024-01697
- Event Type
- Injury
- Date Received
- January 24, 2024
- Date of Event
- January 11, 2024
- Report Date
- January 24, 2024
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- MRA
- PMA / PMN Number
- P070026
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 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). INVESTIGATION SUMMARY : ACCORDING TO THE INFORMATION RECEIVED, ¿LINER BREAKAGE INTRA-OP & SHELL BREAKAGE INTRA-OP. PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY. THE CERAMIC LINER WAS FOUND TO BE FRACTURED. AT THE SAME TIME, THE SHELL WAS FOUND TO BE DAMAGED. CHANGED ANOTHER SHELL AND LINER TO COMPLETE THE SURGERY. THERE WAS A 1 HOUR DELAY IN THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION NOW¿. THE CERAMIC LINER WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. 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 "240515 FINAL REPORT KIV 24 02 08_RP.PDF". VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT EA DELTA CER INSERT 36IDX52OD HAS FRACTURED INTO TWO (2) LARGE, FIFTEEN SMALL (15) AND A NUMBER OF VERY SMALL FRAGMENTS. HOWEVER, THE CERAMIC LINER CANNOT BE COMPLETELY RECONSTRUCTED. THERE ARE FRAGMENTS MISSING WHICH COULD POTENTIALLY YIELD FURTHER INFORMATION IF THEY WERE AVAILABLE. METAL TRANSFER PATTERNS OF ERRATIC APPEARANCE WERE FOUND ON THE LINER. ADDITIONALLY, SYMMETRICAL METAL TRANSFER PATTERNS AROUND THE WHOLE CIRCUMFERENCE OF THE CENTER AND TOP SECTION OF THE TAPER WAS NOT ABLE TO BE EVALUATED SUFFICIENTLY DUE TO THE HIGH NUMBER OF SMALL FRAGMENTS FROM THE TAPER REGION AND DUE TO MISSING FRAGMENTS. THEREFORE, THE PRIMARY METAL TRANSFER THAT SUGGEST A SYMMETRICAL TAPER FIT BETWEEN THE CERAMIC LINER AND ACETABULAR CUP CANNOT BE EVALUATED. FURTHERMORE, THE INTENSIVE METAL TRANSFER AT THE INNER SURFACE OF THE INSERT, INDICATES THAT THE CERAMIC LINER WAS ADDITIONALLY FRACTURED DUE TO POINT LOADS. THESE POINT LOADS WERE MOST LIKELY GENERATED BY THE SURGEON TO FRACTURE THE LINER INTRO FRAGMENTS AND TO REMOVE THE BROKEN FRAGMENTS FROM THE ACETABULAR CUP. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH THE CERAMIC LINER FAILURE CANNOT BE TRACED TO DESIGN OR MANUFACTURING, A DEFINITE ROOT CAUSE CANNOT BE ESTABLISHED DUE TO THE HIGH NUMBER OF SMALL FRAGMENTS AND SECONDARY DAMAGE. CONSIDERATION MUST BE GIVEN TO ALL POTENTIAL INFLUENCES DURING THE SURGICAL PROCESS. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [121881752 / 4235761] 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 EA DELTA CER INSERT 36IDX52OD 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 LINER 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 [121881752 / 4235761] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. H11 ADDITIONAL NARRATIVE: CORRECTED: H3.
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.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿LINER BREAKAGE INTRA-OP & SHELL BREAKAGE INTRA-OP. PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY. THE CERAMIC LINER WAS FOUND TO BE FRACTURED. AT THE SAME TIME, THE SHELL WAS FOUND TO BE DAMAGED. CHANGED ANOTHER SHELL AND LINER TO COMPLETE THE SURGERY. THERE WAS A 1 HOUR DELAY IN THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION NOW¿. THE CERAMIC LINER WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. 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 "(B)(6) FINAL REPORT KIV 24 02 08_RP.PDF". VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT EA DELTA CER INSERT 36IDX52OD HAS FRACTURED INTO TWO (2) LARGE, FIFTEEN SMALL (15) AND A NUMBER OF VERY SMALL FRAGMENTS. HOWEVER, THE CERAMIC LINER CANNOT BE COMPLETELY RECONSTRUCTED. THERE ARE FRAGMENTS MISSING WHICH COULD POTENTIALLY YIELD FURTHER INFORMATION IF THEY WERE AVAILABLE. METAL TRANSFER PATTERNS OF ERRATIC APPEARANCE WERE FOUND ON THE LINER. ADDITIONALLY, SYMMETRICAL METAL TRANSFER PATTERNS AROUND THE WHOLE CIRCUMFERENCE OF THE CENTER AND TOP SECTION OF THE TAPER WAS NOT ABLE TO BE EVALUATED SUFFICIENTLY DUE TO THE HIGH NUMBER OF SMALL FRAGMENTS FROM THE TAPER REGION AND DUE TO MISSING FRAGMENTS. THEREFORE, THE PRIMARY METAL TRANSFER THAT SUGGEST A SYMMETRICAL TAPER FIT BETWEEN THE CERAMIC LINER AND ACETABULAR CUP CANNOT BE EVALUATED. FURTHERMORE, THE INTENSIVE METAL TRANSFER AT THE INNER SURFACE OF THE INSERT, INDICATES THAT THE CERAMIC LINER WAS ADDITIONALLY FRACTURED DUE TO POINT LOADS. THESE POINT LOADS WERE MOST LIKELY GENERATED BY THE SURGEON TO FRACTURE THE LINER INTRO FRAGMENTS AND TO REMOVE THE BROKEN FRAGMENTS FROM THE ACETABULAR CUP. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH THE CERAMIC LINER FAILURE CANNOT BE TRACED TO DESIGN OR MANUFACTURING, A DEFINITE ROOT CAUSE CANNOT BE ESTABLISHED DUE TO THE HIGH NUMBER OF SMALL FRAGMENTS AND SECONDARY DAMAGE. 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 [121881752 / 4235761] 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 EA DELTA CER INSERT 36IDX52OD 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 LINER 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 [121881752 / 4235761] 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.
LINER BREAKAGE INTRA-OP & SHELL BREAKAGE INTRA-OP. PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY. THE CERAMIC LINER WAS FOUND TO BE FRACTURED. AT THE SAME TIME, THE SHELL WAS FOUND TO BE DAMAGED. CHANGED ANOTHER SHELL AND LINER TO COMPLETE THE SURGERY. THERE WAS A 1 HOUR DELAY IN THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.
ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PLEASE PROVIDE THE ORIGINAL IMPLANTATION DATE? (B)(6) 2024. B. WAS THERE ANY PATIENT HARM RELATED TO THE EVENT? THERE WAS A 1 HOUR DELAY IN THE PROCEDURE. C. KINDLY CONFIRM THE ALERT DATE OF THE COMPLAINT? WHEN WERE YOU MADE AWARE OF THE EVENT? (B)(6) 2024. D. KINDLY VERIFY THE EVENT DATE? 11TH JAN 2024 . E. DID IT BREAK INTO TWO OR MORE PIECES? IF YES, WERE ALL THE FRAGMENTS RETRIEVED FROM THE PATIENT? YES, IT BREAK INTO MORE THAN TWO PIECES. AND THE FRAGMENTS RETRIEVED FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1174203 | EA DELTA CER INSERT 36IDX52OD | HIP CERAMIC ACETABULAR LINERS | MRA | DEPUY ORTHOPAEDICS INC US | 4235761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | PINN MULTIHOLE W/GRIPTION 52MM |