DELTA CER HEAD 12/14 32MM +1
Report
- Report Number
- 1818910-2024-11061
- Event Type
- Injury
- Date Received
- May 20, 2024
- Date of Event
- May 9, 2024
- Report Date
- May 20, 2024
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LZO
- UDI-DI
- 10603295033431
- PMA / PMN Number
- K031803
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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, ¿HCP IS REPORTING A FRACTURED CERAMIC HIP COMPONENT LEFT SIDE. SEE X-RAYS. WE WOULD HAVE A PATIENT ON TUESDAY ((B)(6) 2024) WHO HAS A BROKEN CERAMIC INLAY OR HEAD¿. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER RADIOLOGICAL IMAGES WERE PROVIDED FOR REVIEW. (B)(4). REVIEW OF THE RADIOLOGICAL IMAGE EVIDENCE REVEALED MULTIPLE BROKEN CERAMIC FRAGMENTS NEAR THE FEMORAL HEAD MOST LIKELY FROM THE CERAMIC LINER. THE CIRCUMFERENCE OF THE FEMORAL HEAD ON THE RADIOGRAPHS PROVIDED APPEARS TO BE CONTINUOUS, WITH NO EVIDENCE OF FRACTURE. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136532310 / 4274517] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE DELTA CER HEAD 12/14 32MM +1 WOULD NOT 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 : 1) QUANTITY MANUFACTURED: (B)(4), 2) DATE OF MANUFACTURE: 20-OCT-2023, 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE, 4) EXPIRY DATE: 30-SEP-2028, 5) IFU REFERENCE: 09020071. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136532310 / 4274517] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. CORRECTED: D4 PRIMARY UDI NUMBER.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : ACCORDING TO THE INFORMATION RECEIVED, ¿HCP IS REPORTING A FRACTURED CERAMIC HIP COMPONENT LEFT SIDE. SEE X-RAYS. WE WOULD HAVE A PATIENT ON TUESDAY ((B)(6) 2024) WHO HAS A BROKEN CERAMIC INLAY OR HEAD¿. THE PRODUCT 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. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE DELTA CER HEAD 12/14 32MM +1 WAS NOT FRACTURED. ON THE POLISHED OUTER SURFACE OF THE FEMORAL HEAD AN AREA OF INTENSIVE METAL TRANSFER CAN BE FOUND, CONSISTENT WITH RECURRING CONTACTS WITH THE ACETABULAR CUP AFTER THE REPORTED FRACTURE OF THE CERAMIC LINER. ADDITIONALLY, THIN CONCENTRIC LINERS WERE OBSERVED OVER THE WHOLE CIRCUMFERENCE OF THE TAPER'S TOP SECTION, THIS METAL TRANSFER PATTERNS INDICATES A CORRECT TAPER FIT BETWEEN THE FEMORAL HEAD AND STEM. THE OBSERVED CONDITION OF THE FEMORAL HEAD DOES NOT REPRESENT A DEVICE NONCONFORMANCE AND DOES NOT PROVIDE ANY INDICATION ANY INDICATION REGARDING A POSSIBLE CAUSE FOR THE FAILURE OF THE INSERT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136532310 / 4274517] 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 NOT CONFIRMED AS THE OBSERVED CONDITION OF THE DELTA CER HEAD 12/14 32MM +1 WOULD NOT 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 SHOWS 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. 1) QUANTITY MANUFACTURED: (B)(4), 2) DATE OF MANUFACTURE: 20-OCT-2023, 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE, 4) EXPIRY DATE: 30-SEP-2028, 5) IFU REFERENCE: 09020071. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136532310 / 4274517] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿HCP IS REPORTING A FRACTURED CERAMIC HIP COMPONENT LEFT SIDE. SEE X-RAYS. WE WOULD HAVE A PATIENT ON TUESDAY (14.5.24) WHO HAS A BROKEN CERAMIC INLAY OR HEAD¿. THE PRODUCT 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)(4)". VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE DELTA CER HEAD 12/14 32MM +1 WAS NOT FRACTURED. ON THE POLISHED OUTER SURFACE OF THE FEMORAL HEAD AN AREA OF INTENSIVE METAL TRANSFER CAN BE FOUND, CONSISTENT WITH RECURRING CONTACTS WITH THE ACETABULAR CUP AFTER THE REPORTED FRACTURE OF THE CERAMIC LINER. ADDITIONALLY, THIN CONCENTRIC LINERS WERE OBSERVED OVER THE WHOLE CIRCUMFERENCE OF THE TAPER'S TOP SECTION, THIS METAL TRANSFER PATTERNS INDICATES A CORRECT TAPER FIT BETWEEN THE FEMORAL HEAD AND STEM. THE OBSERVED CONDITION OF THE FEMORAL HEAD DOES NOT REPRESENT A DEVICE NONCONFORMANCE AND DOES NOT PROVIDE ANY INDICATION ANY INDICATION REGARDING A POSSIBLE CAUSE FOR THE FAILURE OF THE INSERT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136532310 / (B)(6)] 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 NOT CONFIRMED AS THE OBSERVED CONDITION OF THE DELTA CER HEAD 12/14 32MM +1 WOULD NOT 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 SHOWS 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. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 20-OCT-2023. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE. 4) EXPIRY DATE: 30-SEP-2028. 5) IFU REFERENCE: (B)(4). DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136532310 / (B)(6)] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING.
PRODUCT COMPLAINT # ==> (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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). 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.
ADDITIONAL INFORMATION RECEIVED: 1. INDICATION FOR IMPLANTATION: COXARTHROSIS LEFT, Z.N. HIP TEP RE 2020, HERE SYMPTOM-FREE, CLINICAL PAIN AND RESTRICTION OF MOVEMENT, RADIOLOGICAL COXARTHROSIS STAD 4 ACCORDING TO (B)(6). 2. IMPLANTATION/REVISION DATE, IF NECESSARY PLANNED REVISION DATE: IMPLANTATION (B)(6) 2024, REVISION: (B)(6) 2024. 3. SEE ABOVE, ADDITIONALLY, ANEURYSM COILING LEFT AT SAB. 4. WHICH COMPONENTS WERE REMOVED DURING THE REVISION OPERATION? WHICH COMPONENTS WERE USED FOR THE NEW SUPPLY? WE ASK YOU FOR PRECISE INFORMATION ABOUT THE MANUFACTURER AND TRADE NAME OF THE MEDICAL DEVICES, THE CATALOG NUMBER, THE BATCH NUMBER: REMOVED: INLAY CERAMIC CERAMAX, SIZE 50 HEAD SIZE 32MM, LOT: 4029764, REF: (B)(4), MANUFACTURER: DEPUYSYNTHES. HIP HEAD, CERAMIC HEAD 32MM NECK LENGTH +1MM (S), LOT: 4274517, REF: (B)(4), MANUFACTURER: DEPUYSYNTHES. RE-SUPPLY: INLAY MARATHON PE-INLAY NEUTRAL SIZE 50 HEAD SIZE 28MM, LOT: M2590N, REF: (B)(4). MANUFACTURER: DEPUYSYNTHES. BIOBALL ADAPTER 12/14 STANDARD S (-3.0) LOT: MS2015884. REF:(B)(4), MANUFACTURER: MERETE GMBH. BIOBALL DELTA 12/14 PLUG-IN HEAD 28MM. LOT: 7011881893/11. REF: (B)(4), MANUFACTURER: MERETE GMBH. 5. WHERE ARE THE EXPORTED PRODUCTS LOCATED, OR WHO CARRIES OUT THE MATERIAL-TECHNICAL EXAMINATION? THE MANUFACTURER: DEPUYSYNTHES HAS REQUESTED THE EXPORTED PRODUCTS. 6. ARE THE EXPORTED COMPONENTS AVAILABLE TO THE MANUFACTURER FOR EXAMINATION, IF ANY, THE TEST RESULTS/X-RAYS/SURGICAL REPORTS/PHOTOS OF THE PRODUCT CONCERNED? EVERYTHING THAT IS REQUESTED IS ALLOWED BY THE AFFECTED PATIENT. 7. NUMBER OF COMPARABLE INCIDENTS. 1 CASE IN 2023.
IT WAS REPORTED THAT A FRACTURE EVENT OCCURRED ON (B)(6) 2024 AT AROUND 14 NOON WITHOUT TRAUMA. THE PATIENT PRESENTED AT OUR CENTRAL EMERGENCY ROOM AROUND 18 THAT EVENING. DOI: (B)(6) 2024 DOE: (B)(6) 2024 AFFECTED SIDE: LEFT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1468926 | DELTA CER HEAD 12/14 32MM +1 | ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS | LZO | DEPUY ORTHOPAEDICS INC US | 4274517 | 10603295033431 | |
| 2304019 | DELTA CER HEAD 12/14 32MM +1 | ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS | LZO | DEPUY ORTHOPAEDICS INC US | 4274517 | 10603295033431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention | DELTA CER INSERT 32ID X 50OD. |