DELTA CER HEAD 9/10 32MM -3
Report
- Report Number
- 1818910-2023-18292
- Event Type
- Injury
- Date Received
- September 7, 2023
- Date of Event
- August 22, 2023
- Report Date
- September 7, 2023
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- MRA
- PMA / PMN Number
- P070026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, "ON (B)(6) 2013, THE PRIMARY SURGERY WAS PERFORMED WITH THE IMPLANT IN QUESTION. ON AUG. 22, 2023, THE SALE REP WAS INFORMED THAT THE HEAD WAS BROKEN. THIS IS A CASES OF HAVING NORMAL LIFE, NOT CAUSED BY ACCIDENTS. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023. SROM16-11 30+4 NECK AND 30-3 HEAD WILL BE USED. THE SURGEON REQUESTED WHETHER THERE WERE SIMILAR CASES (DOMESTIC OR OVERSEAS), THE CAUSE OF THE BREAKAGE, AND AN EXAMINATION OF THE IMPLANT IN QUESTION. NO FURTHER INFORMATION IS AVAILABLE". THE PRODUCT 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 "240319 FINAL REPORT KIV 23 09 13_RP.PDF". VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE DELTA CER HEAD 9/10 32MM -3 HAS FRACTURED INTO FOUR (4) LARGE AND ONE (1) SMALL FRAGMENT. HOWEVER, THE CERAMIC LINER WAS NOT ABLE TO BE COMPLETELY RECONSTRUCTED, THERE ARE FRAGMENTS MISSING WHICH COULD POTENTIALLY YIELD FURTHER INFORMATION IF THEY WERE AVAILABLE. METAL TRANSFER OF ERRATIC APPEARANCE CAN BE FOUND ON THE OUTER SURFACE AND ON THE FRACTURE SURFACES, MOST LIKELY CAUSED BY CHAFING BETWEEN METAL PARTS AND THE BROKEN FRAGMENTS OF THE CERAMIC HEAD, EITHER AFTER THE PRIMARY FRACTURE OF DURING THE SURGICAL PROCEDURES. ADDITIONALLY, THIN CONCENTRIC LINES OF METAL TRANSFER THAT SUGGEST A SYMMETRICAL TAPER FIT BETWEEN THE FEMORAL HEAD AN THE METAL TAPER OF THE STEM WERE NOT FOUND EQUALLY DISTRIBUTED ON THE CONICAL BORE SURFACE OF THE HEAD. HOWEVER, IT CANNOT BE DETERMINED WHETHER THE CONCENTRIC LINES ARE MISSING DUE TO CONTAMINATION, E.G. WITH BLOOD OR TISSUE, DURING THE ASSEMBLY OF THE FEMORAL HEAD AND STEM IN THE PRIMARY SURGERY. OR IF IT IS MISSING DUE TO SECONDARY SURFACE DETERIORATION AFTER THE PRIMARY FRACTURE EVENT. THE FRACTURE SURFACES OF THE LARGE FRAGMENTS PRESENT SIGNS OF SECONDARY CHIP-OFFS SINCE THE FRAGMENTS CHAFED AGAINST EACH OTHER IN THE PERIOD BETWEEN THE PRIMARY FRACTURE EVENT AND THE DELIVERY OF THE FRAGMENTS FOR INVESTIGATION. IF THE PRIMARY FRACTURE EVENT IS CAUSED BY HOOP STRESSES INSIDE THE CONICAL BORE OF THE CERAMIC HEAD, THE PRIMARY FRACTURE SURFACE COINCIDES WITH THE FEMORAL HEAD AXIS. HOWEVER, THE FRACTURE ORIGIN CANNOT BE DETERMINED DUE TO THE OBSERVED CONDITION OF THE FRACTURE SURFACES. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH THE FEMORAL HEAD FAILURE CANNOT BE TRACED TO DESIGN OR MANUFACTURING, A DEFINITE ROOT CAUSE CANNOT BE ESTABLISHED. 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 [136532110 / 3528938] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. THE DENSITY OF THE FEMORAL HEAD WAS ANALYZED AND FOUND TO COMPLY WITH THE DELIVERY SPECIFICATION FOR BIOLOX DELTA COMPONENTS. THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS MEETS THE REQUIREMENTS SPECIFIED AT THE TIME OF PRODUCTION, TOO. THERE IS NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DELTA CER HEAD 9/10 32MM -3 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 ==> THE CERAMIC INSERT BELONGS TO THE SHOP ORDER (B)(4). PROTOCOLS AND CERTIFICATE OF CONFORMANCE WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE DATA OBTAINED ON THE FEMORAL HEAD CONFIRMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE DENSITY OF THE FEMORAL HEAD WAS ANALYZED AND FOUND TO COMPLY WITH THE DELIVERY SPECIFICATION FOR BIOLOX DELTA COMPONENTS. THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS MEETS THE REQUIREMENTS SPECIFIED AT THE TIME OF PRODUCTION, TOO. THERE IS NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT. DEVICE HISTORY REVIEW ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136532110 / 3528938] 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # : PC-(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.
IT WAS REPORTED THAT THE SALE REP WAS INFORMED THAT THE HEAD WAS BROKEN. THIS IS A CASES OF HAVING NORMAL LIFE, NOT CAUSED BY ACCIDENTS. THE REVISION SURGERY IS SCHEDULED ON . SROM16-11 30+4 NECK AND 30-3 HEAD WILL BE USED. THE SURGEON REQUESTED WHETHER THERE WERE SIMILAR CASES (DOMESTIC OR OVERSEAS), THE CAUSE OF THE BREAKAGE, AND AN EXAMINATION OF THE IMPLANT IN QUESTION. DOI: (B)(6) 2013. DOR: (B)(6) 2023. UNKNOWN HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 926106 | DELTA CER HEAD 9/10 32MM -3 | HIP CERAMIC FEMORAL HEADS | MRA | DEPUY ORTHOPAEDICS INC US | 3528938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | SROM 9/10 16X11X130 30. |