ATTUNE EM TIBIAL PROX UPROD
Report
- Report Number
- 1818910-2025-05536
- Event Type
- Malfunction
- Date Received
- April 11, 2025
- Date of Event
- January 1, 2025
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- LXH
- UDI-DI
- 10603295434030
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, "CUSTOMER REPORTED: DEFECT ITEM. THE ITEM CAN NO LONGER BE ROTATED." THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE EVIDENCE PROVIDED WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT JAMMED/SEIZED. FUNCTIONALITY ISSUES AND DEVICE INTERACTION ISSUES CANNOT BE EVALUATED THROUGH A PHOTO INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PG232071 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED COMPLAINT CONDITION. 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 COMPLAINT CONDITION. AS PART OF MEDTECH ORTHOPEDICS 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: 30-AGU-2013. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: 1 QHF (QUALITY HOLD FILE) FOR 1 PC MISSING GLASS BEAD. THIS PART WAS REWORK, REINSPECTED AND SENT WITH THE ORDER. 4) EXPIRY DATE: N/A. 5) IFU REFERENCE: 090200836, REV. C. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PG232071 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PG232071 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 (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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H3, H6 INVESTIGATION SUMMARY: THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPEDICS; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE EVIDENCE PROVIDED WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT JAMMED/SEIZED. FUNCTIONALITY ISSUES AND DEVICE INTERACTION ISSUES CANNOT BE EVALUATED THROUGH A PHOTO INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED COMPLAINT CONDITION. 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 COMPLAINT CONDITION. AS PART OF MEDTECH ORTHOPEDICS 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. THE DEVICE LOT IS UNKNOWN; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ACCORDING TO THE INFORMATION PROVIDED: "CUSTOMER REPORTED: DEFECT ITEM. THE ITEM CAN NO LONGER BE ROTATED. NO PATIENT INVOLVEMENT". THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE ATTUNE EM TIBIAL PROX UPROD REVEALED SIGNS OF HEAVY USAGE ON ITS OVERALL SURFACE, INCLUDING LITTLE DEFORMATIONS AROUND THE SHAFT OF THE RED KNOB. ADDITIONALLY, THE WHITE INK BACKFILLED INTO THE DEBOSSED MARKINGS WERE FOUND WORN OFF AND MISSING. THE OBSERVED CONDITIONS OF THE DEVICE WERE IDENTIFIED AS END-OF-LIFE INDICATORS, DAMAGE CONSISTENT WITH REPEATED USE AND SERVICING. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE AND INSPECTION OF THE DEVICE IN CLINICAL PRACTICE. AS THE DEVICE CAN BE DAMAGED ON THE FIRST OR 100TH USE, THE DEVICE MUST BE PROPERLY INSPECTED PRIOR TO EACH SURGICAL USE. REFER TO THE DEVICE/COUNTRY SPECIFIC IFU FOR INFORMATION RELATED TO END OF LIFE, REPROCESSING INSTRUCTIONS, AND INSPECTION PROCEDURES. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. TWO FUNCTIONAL TESTS WERE PERFORMED FOR THE ATTUNE EM TIBIAL PROX UPROD: THE FIRST ONE TESTING THE RED KNOB BY ITSELF; AND THE SECOND ONE USING A J&J MEDTECH ORTHOPAEDICS SAMPLE (ATTUNE EM TIBIAL DIST UPROD, D254400003) AS MATING COMPONENT. FIRST FUNCTIONAL TEST REVEALED THE LOCKING KNOB COULD NOT ROTATE AS INTENDED, AS A CONSEQUENCE OF THE WEAR APPEARANCE OF ITS SHAFT, LEAVING THE KNOB TO ROTATE MORE THAT EXPECTED (CONFIRMING REPORTED EVENT). HOWEVER, THE SECOND FUNCTIONAL TEST REVEALED, THAT EVEN WITH THE CONDITION OBSERVED ON THE KNOB SHAFT, THE MATING COMPONENT COULD BE ASSEMBLED/DISASSEMBLED AND LOCK WITH NO ISSUE. NO SIGNS OF UNDESIRED MOVEMENT WAS OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PG232071 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE EM TIBIAL DIST UPROD 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 1) QUANTITY MANUFACTURED: 50 2) DATE OF MANUFACTURE: 30-AGU-2013 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: 1 QHF (QUALITY HOLD FILE) FOR 1 PC MISSING GLASS BEAD. THIS PART WAS REWORK, REINSPECTED AND SENT WITH THE ORDER. 4) EXPIRY DATE: N/A 5) IFU REFERENCE: 090200836, REV. C. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PG232071 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PG232071 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. H11 ADDITIONAL NARRATIVE: ADDED: G1 (MANUFACTURING SITE NAME) CORRECTED: H3, H4.
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. H11 ADDITIONAL NARRATIVE: ADDED: D9, D10. 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. H11 ADDITIONAL NARRATIVE: ADDED: D4 (LOT), H4. CORRECTED: D4 (PRIMARY UDI NUMBER, CATALOG), D1, D2B. 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 THERE WAS A DEFECTIVE ITEM ON AN UNKNOWN DATE. THE ITEM COULD NO LONGER BE ROTATED. THERE WAS NO PATIENT INVOLVEMENT; ISSUE WAS NOTED PRE-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1080939 | ATTUNE EM TIBIAL PROX UPROD | ATTUNE INSTRUMENTS : ALIGNMENT DEVICES | LXH | DEPUY IRELAND - 9616671 | PG232071 | 10603295434030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ATTUNE MES SIZING/ROT GDE |