VMP ENDURANCE 80G
Report
- Report Number
- 1818910-2024-21004
- Event Type
- Malfunction
- Date Received
- October 7, 2024
- Date of Event
- October 1, 2024
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- HTQ
- UDI-DI
- 10603295357148
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED, ¿DURING THE SURGERY, IT WAS DISCOVERED THAT ONE OF THE TWO CEMENT MONOMER LIQUID BOTTLES HAD A DISLODGED WELD WHEN THE PRODUCT WAS OPENED. THEREFORE, THE MONOMER LIQUID THAT HAD A DISLODGED WELD WAS REPLACED WITH A SPARE PRODUCT." PRODUCT DESCRIPTION: VMP ENDURANCE 80G, PRODUCT CODE: 3172080, LOT NUMBER: 4127351, MANUFACTURING DATE: 2023-04-03, EXPIRY DATE: 2025-03-31, QUANTITY: (B)(4). THERE WAS 1 NON-CONFORMANCES ON THIS LOT. ON REVIEW OF THE APPLICABLE NCS NONE HAVE BEEN IDENTIFIED WHICH WOULD CONTRIBUTE TO THE COMPLAINT EVENT. ALL QC AND MICROBIOLOGY TESTING MET SPECIFICATION. A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED. 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. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: PRODUCT DESCRIPTION: VMP ENDURANCE 80G, PRODUCT CODE: 3172080, LOT NUMBER: 4127351, MANUFACTURING DATE: 2023-04-03, EXPIRY DATE: 2025-03-31, QUANTITY: (B)(4). DEVICE HISTORY REVIEW: A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED. H11 ADDITIONAL NARRATIVE: CORRECTED: D4 (LOT, PRIMARY UDI NUMBER).
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE SURGERY, IT WAS DISCOVERED THAT ONE OF THE TWO CEMENT MONOMER LIQUID BOTTLES HAD A DISLODGED WELD WHEN THE PRODUCT WAS OPENED. THEREFORE, THE MONOMER LIQUID THAT HAD A DISLODGED WELD WAS REPLACED WITH A SPARE PRODUCT. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION REVEALED THE FOLLOWING CONDITIONS ON THE VMP ENDURANCE 80G'S PACKAGING: 1) OUTER PACKAGING (BOX) WAS FOUND OPEN WITH SIGNS OF MANIPULATION; 2) LIQUID VIALS WERE NOT RETURNED FOR EVALUATION; AND THE 3) METALLIC PACKAGING WAS FOUND COMPLETELY SEALED ON ALL ITS EDGES. SINCE LIQUID VIALS WERE NOT RETURNED FOR EVALUATION, THERE IS NO CERTAINTY OF THE CONDITION OF THE LIQUID VIALS, THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. FURTHERMORE, ALTHOUGH THE PACKAGING WAS RETURNED IN AN OPEN CONDITION, EVIDENCE SUGGESTS THE DEVICE HAD BEEN SEALED AND PACKAGED AT THE MANUFACTURER PRIOR TO WHEN IT WAS OPENED. THEREFORE, NO EVIDENCE SUGGESTS AN ERROR IN THE MANUFACTURING THAT COULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE VMP ENDURANCE 80G WOULD HAVE NOT CONTRIBUTED 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 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 4147294 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4147294 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. H11 ADDITIONAL NARRATIVE: CORRECTED: H3.
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 THAT 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 THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
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 NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.
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 THAT 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 THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE SURGERY, IT WAS DISCOVERED THAT ONE OF THE TWO CEMENT MONOMER LIQUID BOTTLES HAD A DISLODGED WELD WHEN THE PRODUCT WAS OPENED. THEREFORE, THE MONOMER LIQUID THAT HAD A DISLODGED WELD WAS REPLACED WITH A SPARE PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.
ADDITIONAL INFORMATION WAS RECEIVED: PLEASE CONFIRM WHAT WAS THE EXACT ALLEGATION.: THE MONOMER LIQUID BOTTLE IN QUESTION HAD A DISLODGED WELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 247061 | VMP ENDURANCE 80G | BONE CEMENT : BONE CEMENT | HTQ | DEPUY ORTHOPAEDICS INC US | 4147294 | 10603295357148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |