ATTUNE PS FEM LT SZ 8 CEM
Report
- Report Number
- 1818910-2025-19618
- Event Type
- Injury
- Date Received
- November 13, 2025
- Date of Event
- August 12, 2022
- Report Date
- November 12, 2025
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- JWH
- UDI-DI
- 10603295041658
- PMA / PMN Number
- P830055
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- 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. H11 ADDITIONAL NARRATIVE: ADDED: A2, A3A, B5, B7, D4(LOT)(CATALOG)(EXPIRATION DATE)(PRIMARY UDI NUMBER), G4(PMA/ 510(K), D10(CONCOMITANT), H4 CORRECTED: A1, D1, D2A. 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- NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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- THE DEVICE LOT NUMBER 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). 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: B5, B6. 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 (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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED, ¿ON (B)(6) 2017, THE PATIENT HAD A LEFT KNEE TOTAL KNEE ARTHROPLASTY. CONSEQUENTLY, THE PATIENT BEGAN EXPERIENCING SEVERE AND PERSISTENT PAIN, DISCOMFORT, SWELLING, INSTABILITY, AND DIFFICULTY AMBULATING. ON (B)(6) 2022, PATIENT UNDERWENT REVISION SURGERY DUE TO MECHANICAL LOOSENING OF THE TIBIA, AND OSTEOLYSIS OF MEDIAL AND LATERAL FEMORAL CONDYLES.¿ PRODUCT DESCRIPTION: ATTUNE PS FEM LT SZ 8 CEM, PRODUCT CODE: 150410108, QUANTITY OF MANUFACTURED (B)(4), DATE OF MANUFACTURING- 09-OCT-2017, EXPIRY DATE- 30-SEP-2027. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: ATTUNE PS FEM LT SZ 8 CEM PRODUCT CODE: 150410108 LOT NUMBER: 8639288 AND FIVE NON-CONFORMANCES WERE IDENTIFIED, HOWEVER NOT RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. 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. DEVICE HISTORY LOT: PRODUCT DESCRIPTION: ATTUNE PS FEM LT SZ 8 CEM, PRODUCT CODE: 150410108, QUANTITY OF MANUFACTURED (B)(4), DATE OF MANUFACTURING- 09-OCT-2017, EXPIRY DATE- 30-SEP-2027. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: ATTUNE PS FEM LT SZ 8 CEM PRODUCT CODE: 150410108 LOT NUMBER: 8639288 AND FIVE NON-CONFORMANCES WERE IDENTIFIED, HOWEVER NOT RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. ADDED: D9, H4. 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 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: B7. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
ADDITIONAL INFORMATION RECEIVED: DOI (B)(6) 2017: MALE PATIENT RECEIVED A LEFT DEPUY ATTUNE PRIMARY KNEE TO TREAT SEVERE DJD. THE PATELLA WAS NOT RESURFACED, AND THE FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED WITH DEPUY SMARTSET CEMENT X2. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PART/LOT INFORMATION IS PROVIDED ON PP.5-6. DOR (B)(6) 2022: 58-YEAR-OLD MALE PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT CHRONIC PAIN, INSTABILITY, AND WALKING DIFFICULTY SECONDARY TO FEMORAL OSTEOLYSIS AND LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED FEMORAL OSTEOLYSIS AND ABUNDANT FEMORAL OSTEOPHYTES. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REMOVED. FEMORAL OSTEOLYSIS WAS CURETTED WHEN THE FEMORAL COMPONENT WAS REMOVED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT RECEIVED A COMPETITOR CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE POSTOPERATIVE SWELLING AND VENOUS DOPPLER NOTED ON (B)(6) 2022 WAS RELATED TO THE COMPETITOR KNEE AND NOT ASSOCIATED WITH A DEPUY DEVICE OR PROCEDURE.
MEDICAL RECORDS REVIEW ((B)(4) MEDICAL RECORDS AD (B)(6) 2026): ON (B)(6) 2022, PATIENT WAS SEEN IN PHYSICIAN'S OFFICE TO ADDRESS SEVERE PAIN, DISCOMFORT AND INSTABILITY IN HIS LEFT KNEE. THE LEFT KNEE WAS AN ATTUNE TOTAL KNEE ARTHROPLASTY. RADIOGRAPHS AP LATERAL MERCHANT ROSENBERG VIEWS OF THE LEFT KNEE DEMONSTRATED INCREASED LUCENCY SURROUNDING THE TIBIA AND SUBTLE LUCENCY SURROUNDING THE TIBIAL KEEL IN THE LATERAL VIEW. THE FEMORAL COMPONENT DEMONSTRATED MILD LUCENCY SURROUNDING THE ANTERIOR FLANGE. IMPRESSION: CEMENTED LEFT TOTAL KNEE ARTHROPLASTY POSTERIOR STABILIZED ROTATING PLATFORM IMPLANTS WITH CONCERN FOR TIBIAL LUCENCY, POSSIBLE FEMORAL LUCENCY AS WELL. PHYSICAL EXAM: THE LEFT KNEE SHOWS A WELL-HEALED MIDLINE INCISION WITH NO OBVIOUS EFFUSION BUT THERE IS TENDERNESS ON THE TIBIA THAT RADIATES UP THE THIGH. HE HAS DIFFICULTY AMBULATING AND HE IS LIMPING, USING A WALKER AND STATES THAT IS BECAUSE OF HIS LEFT KNEE PAIN HIS TOES ARE WARM PINK AND PERFUSED AND HIS PERONEAL NERVE IS INTACT. THE KNEE DEMONSTRATES NO SIGNIFICANT LAXITY WITH VARUS AND VALGUS STRESS TESTING. ASSESSMENT: 1. STABLE COMPETITOR BRAND RIGHT TOTAL KNEE WITH GOOD OUTCOMES. 2. PAINFUL LEFT TOTAL KNEE WITH TIBIAL COMPONENT LOOSENING, CEMENTED DEPUY ATTUNE PROSTHESIS. ON (B)(6) 2022, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS LONG STANDING LEFT KNEE PAIN, MECHANICAL LOOSENING OF THE TIBIAL TRAY, AND OSTEOLYSIS OF MEDIAL AND LATERAL FEMORAL CONDYLES. THE PATIENT'S PATELLA HAD NOT BEEN RESURFACED PRIOR TO THIS REVISION SURGERY. OPERATIVELY, THERE WAS A LARGE OSTEOLYTIC DEFECT IN THE MEDIAL FEMORAL CONDYLE AND A MODERATE-SIZED OSTEOLYTIC DEFECT IN THE LATERAL FEMORAL CONDYLE WHICH WERE EXCISED. THE CEMENTED FEMUR COMPONENT APPEARED TO BE WELL-FIXED. THE TIBIAL COMPONENT WAS CONFIRMED TO BE LOOSE. IT LIFTED CLEANLY OUT OF THE CEMENT MANTLE WITH NO CEMENT ADHERENT TO THE POSTERIOR BORDER OF THE TIBIAL COMPONENT. THE TIBIAL TRAY IMPLANT COMPONENT REQUIRED LITTLE EFFORT TO REMOVE. THE CEMENT MANTLE, ON THE OTHER HAND, WAS WELL-FIXED, AND REQUIRED CEMENT REMOVAL INSTRUMENTS TO EXTRACT. A COMPETITOR REVISION KNEE SYSTEM, INCLUDING A RESURFACED PATELLA, WERE IMPLANTED TO TREAT.
ON (B)(6) 2017, THE PATIENT HAD A LEFT KNEE TOTAL KNEE ARTHROPLASTY. CONSEQUENTLY, THE PATIENT BEGAN EXPERIENCING SEVERE AND PERSISTENT PAIN, DISCOMFORT, SWELLING, INSTABILITY, AND DIFFICULTY AMBULATING. ON (B)(6) 2022, PATIENT UNDERWENT REVISION SURGERY DUE TO MECHANICAL LOOSENING OF THE TIBIA, AND OSTEOLYSIS OF MEDIAL AND LATERAL FEMORAL CONDYLES. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17141 | ATTUNE PS FEM LT SZ 8 CEM | KNEE FEMORAL IMPLANT | JWH | DEPUY ORTHOPAEDICS INC US | 8639288 | 10603295041658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |