ATTUNE PS RP INSRT SZ8 6MM
Report
- Report Number
- 1818910-2025-03955
- Event Type
- Malfunction
- Date Received
- March 14, 2025
- Date of Event
- February 20, 2025
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- NJL
- UDI-DI
- 10603295052852
- PMA / PMN Number
- P830055
- 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 (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 - OUTER PACKING DAMAGED. IT WAS REPORTED THAT BEFORE THE SURGERY, THE PACKAGING WAS FOUND TO BE DAMAGED (AS THE PHOTO SHOWS), THE SEAL WAS LEAKY, AND THE STERILE ENVIRONMENT OF THE PROSTHESIS WAS COMPROMISED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION REVEALED THE ATTUNE PS RP INSRT SZ8 6MM'S PACKAGING WITH THE FOLLOWING CONDITIONS: 1) PLASTIC COVER WAS STILL ATTACHED TO THE OUTER BOX OF THE IMPLANT; HOWEVER, A RIPPED PORTION WAS IDENTIFIED ON ONE SIDE OF THE BOX; 2) ON THE SAME PORTION, THE OUTER BOX OF THE DEVICE WAS FOUND TO BE DAMAGED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4210226 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. ALTHOUGH THE PACKAGING CAN BE OBSERVED IN A DAMAGED CONDITION, EVIDENCE SUGGESTS THE DEVICE HAD BEEN SEALED AND PACKAGED CORRECTLY AT THE MANUFACTURER PRIOR TO WHEN IT WAS OPENED BY THE CUSTOMER. THEREFORE, NO EVIDENCE SUGGESTS AN ERROR IN THE MANUFACTURING THAT COULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION. ONCE THE PRODUCT LEAVES MEDTECH ORTHOPAEDICS CONTROL, IT IS UNKNOWN WHAT ENVIRONMENTAL/EXTERNAL FACTORS THE FINISHED GOODS PRODUCTS ARE EXPOSED TO. THEREFORE, THE SUSPECTED CAUSE IS TRACED TO IMPROPER HANDLING OUTSIDE THE MEDTECH ORTHOPAEDICS CONTROL. NEVERTHELESS, FOR THE COMPROMISED STERILITY ALLEGATION, AS THE DEVICE PACKAGING COUNTS WITH OTHER STERILE BARRIERS INSIDE THE OUTER PACKAGING AND PLASTIC COVER, SUCH AS THE BLISTER AND THE INNER STERILE BARRIER SEALED, THERE IS NO CLEAR EVIDENCE OF A STERILITY BREACH. THEREFORE, WITH INFORMATION PROVIDED, NO OBSERVATIONS PERTAINING TO THE NATURE OF THIS REPORTED ALLEGATION COULD BE IDENTIFIED NOR CONFIRMED. 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 CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE PS RP INSRT SZ8 6MM WOULD HAVE 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 4210226 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. H11 ADDITIONAL NARRATIVE: CORRECTED: H3.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY OUTER PACKING DAMAGED. IT WAS REPORTED THAT BEFORE THE SURGERY, THE PACKAGING WAS FOUND TO BE DAMAGED(AS THE PHOTO SHOWS), THE SEAL WAS LEAKY, AND THE STERILE ENVIRONMENT OF THE PROSTHESIS WAS COMPROMISED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. ¿THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THE OUTER BOX OF THE ATTUNE PS RP INSRT SZ8 6MM'S PACKAGING DAMAGED, DAMAGE WHICH APPEARS TO BE INSIDE OF THE PLASTIC COVER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4210226 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. ALTHOUGH THE PACKAGING CAN BE OBSERVED IN A DAMAGED CONDITION, EVIDENCE SUGGESTS THE DEVICE HAD BEEN SEALED AND PACKAGED CORRECTLY AT THE MANUFACTURER PRIOR TO WHEN IT WAS OPENED BY THE CUSTOMER. THEREFORE, NO EVIDENCE SUGGESTS AN ERROR IN THE MANUFACTURING THAT COULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION. ONCE THE PRODUCT LEAVES MEDTECH ORTHOPAEDICS CONTROL, IT IS UNKNOWN WHAT ENVIRONMENTAL/EXTERNAL FACTORS THE FINISHED GOODS PRODUCTS ARE EXPOSED TO. THEREFORE, THE SUSPECTED CAUSE IS TRACED TO IMPROPER HANDLING OUTSIDE THE MEDTECH ORTHOPAEDICS CONTROL. NEVERTHELESS, FOR THE COMPROMISED STERILITY ALLEGATION, THERE IS NO CLEAR EVIDENCE IF THE PLASTIC COVER HAS RIPPED OFF OR NOT, THEREFORE NO OBSERVATIONS PERTAINING TO THE NATURE OF THIS REPORTED ALLEGATION COULD BE IDENTIFIED NOR CONFIRMED. 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. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE PS RP INSRT SZ8 6MM WOULD HAVE 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 4210226 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4210226 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. H11 ADDITIONAL NARRATIVE: ADDED: D10.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: OUTER PACKING DAMAGED. IT WAS REPORTED THAT BEFORE THE SURGERY, THE PACKAGING WAS FOUND TO BE DAMAGED (AS THE PHOTO SHOWS), THE SEAL WAS LEAKY, AND THE STERILE ENVIRONMENT OF THE PROSTHESIS WAS COMPROMISED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENTS (B)(4). THE PHOTO INVESTIGATION REVEALED THE OUTER BOX OF THE ATTUNE PS RP INSRT SZ8 6MM'S PACKAGING DAMAGED, DAMAGE WHICH APPEARS TO BE INSIDE OF THE PLASTIC COVER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4210226 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. ALTHOUGH THE PACKAGING CAN BE OBSERVED IN A DAMAGED CONDITION, EVIDENCE SUGGESTS THE DEVICE HAD BEEN SEALED AND PACKAGED CORRECTLY AT THE MANUFACTURER PRIOR TO WHEN IT WAS OPENED BY THE CUSTOMER. THEREFORE, NO EVIDENCE SUGGESTS AN ERROR IN THE MANUFACTURING THAT COULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION. ONCE THE PRODUCT LEAVES MEDTECH ORTHOPAEDICS CONTROL, IT IS UNKNOWN WHAT ENVIRONMENTAL/EXTERNAL FACTORS THE FINISHED GOODS PRODUCTS ARE EXPOSED TO. THEREFORE, THE SUSPECTED CAUSE IS TRACED TO IMPROPER HANDLING OUTSIDE THE MEDTECH ORTHOPAEDICS CONTROL. NEVERTHELESS, FOR THE COMPROMISED STERILITY ALLEGATION, THERE IS NO CLEAR EVIDENCE IF THE PLASTIC COVER HAS RIPPED OFF OR NOT, OR IF THE STERILE BARRIER HAS BREACH OUT, THEREFORE NO OBSERVATIONS PERTAINING TO THE NATURE OF THIS REPORTED ALLEGATION COULD BE IDENTIFIED NOR CONFIRMED. 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. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE PS RP INSRT SZ8 6MM WOULD HAVE 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 4210226 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4210226 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.
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. H11 ADDITIONAL NARRATIVE: ADDED: D9. 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 BEFORE THE SURGERY, THE OUTER PACKAGING WAS FOUND TO BE DAMAGED - THE SEAL WAS LEAKY, AND THE STERILE ENVIRONMENT OF THE PROSTHESIS WAS COMPROMISED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1451783 | ATTUNE PS RP INSRT SZ8 6MM | ATTUNE IMPLANT : KNEE TIBIAL INSERT | NJL | DEPUY IRELAND - 9616671 | 4210226 | 10603295052852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ATTUNE PS RP INSRT SZ8 6MM. |