LPS UNIV TIB HIN INS XSM 16MM
Report
- Report Number
- 1818910-2023-07628
- Event Type
- Injury
- Date Received
- April 11, 2023
- Date of Event
- March 17, 2023
- Report Date
- April 11, 2023
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- KRO
- UDI-DI
- 10603295079415
- PMA / PMN Number
- K091453
- 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). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED. PHOTO EVIDENCE AND X-RAYS PROVIDED WERE REVIEWED AND FOUND EVIDENCE OF FRACTURE OF THE LPS UNIV TIB HIN INS XSM 16MM. THE REPORT ALLEGATION CAN BE CONFIRMED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PRODUCT CODE: 198727116. LOT NUMBER: J3940J 1) QUANTITY MANUFACTURED: (B)(4) 2) DATE OF MANUFACTURE: 5/29/2019 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 4) EXPIRY DATE: 04/30/2024 5) IFU REFERENCE:IFU-0902-00-773 DEVICE HISTORY REVIEW: 1) QUANTITY MANUFACTURED: (B)(4) 2) DATE OF MANUFACTURE: 5/29/2019 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 4) EXPIRY DATE: 04/30/2024 5) IFU REFERENCE:IFU-0902-00-773 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: LPS UNIV TIB HIN INS XSM 16MM PRODUCT CODE: 198727116 LOT NUMBER: J3940J AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.
PRODUCT COMPLAINT#: (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED. PHOTO EVIDENCE AND X-RAYS PROVIDED WERE REVIEWED AND FOUND EVIDENCE OF FRACTURE OF THE LPS UNIV TIB HIN INS XSM 16MM. THE REPORT ALLEGATION CAN BE CONFIRMED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PRODUCT CODE: 198727116. LOT NUMBER: J3940J. 1) QUANTITY MANUFACTURED: 8, 2) DATE OF MANUFACTURE: 5/29/2019, 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 4) EXPIRY DATE: 04/30/2024, 5) IFU REFERENCE: IFU-0902-00-773. DEVICE HISTORY REVIEW: 1) QUANTITY MANUFACTURED: 8, 2) DATE OF MANUFACTURE: 5/29/2019, 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 4) EXPIRY DATE: 04/30/2024, 5) IFU REFERENCE: IFU-0902-00-773. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT. DESCRIPTION: LPS UNIV TIB HIN INS XSM 16MM PRODUCT CODE: 198727116, LOT NUMBER: J3940J AND NO NON-CONFORMANCES OR 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 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). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR ANALYSIS. VISUAL ANALYSIS REVEALED THAT FRACTURE OF THE LPS UNIV TIB HIN INS XSM 16MM. THE REPORT ALLEGATION CAN BE CONFIRMED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : PRODUCT CODE: 198727116. LOT NUMBER: J3940J. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 5/29/2019. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 4) EXPIRY DATE: 04/30/2024. 5) IFU REFERENCE:IFU-0902-00-773. DEVICE HISTORY REVIEW: 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 5/29/2019. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 4) EXPIRY DATE: 04/30/2024. 5) IFU REFERENCE:IFU-0902-00-773. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: LPS UNIV TIB HIN INS XSM 16MM PRODUCT CODE: 198727116 LOT NUMBER: J3940J AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. CORRECTED H3.
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT EXPERIENCED PAIN AND INSTABILITY. A SURGICAL TIME EXTENSION OF APPROXIMATELY 30 MINUTES ALSO OCCURRED DUE TO THE PRONOUNCED PERIARTICULAR CALCIFICATIONS.
PATIENT OF (B)(4) WILL BE REVISED AS LPS INLAY RIGHT SIDE FRACTURED AGAIN. REVISION WILL BE FOR PAIN AND INSTABILITY. REVISION IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1861244 | LPS UNIV TIB HIN INS XSM 16MM | LPS AND S-ROM : KNEE TIBIAL INSERT | KRO | DEPUY ORTHOPAEDICS INC US | 1987-27-116 | BFI1DPS | 10603295079415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Required Intervention | LPS UNIV TIB HIN INS XSM 16MM| LPS UNIV TIB HIN INS XSM 16MM| SROM*NRH REPL HINGE PIN/XSM/SM| UNK KNEE FEMORAL HINGE PIN LPS |