REPLICA SM STAT SHT RT 10.5MM
Report
- Report Number
- 1818910-2023-25859
- Event Type
- Injury
- Date Received
- December 21, 2023
- Date of Event
- December 14, 2023
- Report Date
- December 21, 2023
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LPH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- 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. 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). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED: THE PATIENT HAD HER HIP REPLACED IN (B)(6) 2001. SHE HAD A DURALOC CUP AND A REPLICA STEM. RECENTLY, HER REPLICA STEM BROKE IN HALF. SO DOCTOR DECIDED TO PERFORM REVISION SURGERY. THE DOCTOR WAS UNABLE TO REMOVE THE DISTAL PORTION THAT BROKE OFF. SO THAT STAYED IN THE CANAL. LOOSENING OF THE REPLICA STEM IS ALSO INDICATED AT BONE TO IMPLANT INTERFACE. ¿THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENTS (B)(4). DEVICE PHOTO AD (B)(6) 2023 (1), (B)(4). DEVICE PHOTO AD (B)(6)2023 (2), (B)(4).DEVICE PHOTO AD (B)(6) 2023 (3),(B)(4).X-RAY FLIMS AD (B)(6)2023 (4).JPG, (B)(4). X-RAY FLIMS AD (B)(6)2023 (5).JPG, (B)(4). X-RAY FLIMS AD (B)(6)2023 (60.JPG, (B)(4). X-RAY FLIMS AD (B)(6)2023 (07)JPG, (B)(4). X-RAY FLIMS AD 15(B)(6)2023 (08)JPG, (B)(4).X-RAY FILLMS AD (B)(6) 2023, (B)(4). X-RAY FLIMS AD (B)(6) 2023 (1), (B)(4). X-RAY FLIMS AD (B)(6) 2023 (2), (B)(4). X-RAY FLIMS AD (B)(6) 2023 (3)). THE PHOTO/X-RAY INVESTIGATION REVEALED THAT REPLICA SM STAT SHT RT 10.5MM HAS FRACTURED AT THE DISTAL PORTION OF THE STEM.¿ LOOSENING CONDITION IS ALSO CONFIRMED. NEVERTHLESS, NO SIGNS OF WEAR WERE OBSERVED ON THE EVIDENCE PROVIDED. WITH THE INFORMATION PROVIDED IS NOT POSSIBLE TO DETERMINE A POTENTIAL CAUSE AT THIS MOMENT, HOWEVER IN SUPPORT OF THE EVALUATION PERFORMED, THE OBSERVED DAMAGE OF THE REPLICA SM STAT SHT RT 10.5MM MAY HAVE BEEN CAUSED BY EXPOSURE TO IRREGULARITIES IN THE WEIGHT LOADING CAUSED BY UNEVEN FIXATION ALL ACROSS THE STEM AND MOMENTS GENERATED. THE MODE OF FAILURE OF THE DEVICE IS MULTI-FACTORIAL AND CONSIDERATION MUST BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS SURGICAL PROCESS, PATIENT VARIABLES (E.G. ACTIVITY LEVEL AND USE), ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE FRACTURE ALLEGATION WAS CONFIRMED AS THE OBSERVED CONDITION OF THE REPLICA SM STAT SHT RT 10.5MM WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, A POTENTIAL CAUSE CANNOT BE ESTABLISHED AND 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 DEPUY SYNTHES 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 : 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). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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 INFORMATION WAS RECEIVED AND STATED THAT THE IMPLANT DATE WAS SOME TIME IN 2001. NEITHER THE DOCTOR NOR THE PATIENT KNEW THE EXACT DATE. THE ACETABULAR WAS REVISED DUE TO BEING IMPLANTED IN A BAD INCLINATION ANGLE BACK IN 2001. ACCORDING TO THE DOCTOR IT WAS IMPLANTED "TOO VERTICAL". THE LINER & CUP WERE EXPLANTED TOGETHER, MEANING THEY WERE CONNECTED. THE CATALOG NUMBER & LOT OF THE CUP WERE NOT VISIBLE. THE LOT NUMBER OF THE LINER IS VISIBLE. THE LOT NUMBER OF THE STEM WAS PARTIALLY WORN AWAY.
THE PATIENT HAD HER HIP REPLACED IN 2001. IMPLANTED A DURALOC CUP AND A REPLICA STEM. RECENTLY, THE STEM BROKE IN HALF. SO DOCTOR DECIDED TO PERFORM REVISION SURGERY. THE DOCTOR WAS UNABLE TO REMOVE THE DISTAL PORTION THAT BROKE OFF. SO THAT STAYED IN THE CANAL. LOOSENING OF THE REPLICA STEM IS ALSO INDICATED AT BONE TO IMPLANT INTERFACE. THE ACETABULAR WAS REVISED DUE TO BEING IMPLANTED IN A BAD INCLINATION ANGLE BACK IN 2001. ACCORDING TO THE DOCTOR IT WAS IMPLANTED ¿TOO VERTICAL¿. THE LINER & CUP WERE EXPLANTED TOGETHER, MEANING THEY WERE CONNECTED. DOI: 2001, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2153135 | REPLICA SM STAT SHT RT 10.5MM | REPLICA IMPLANTS : HIP FEMORAL STEM | LPH | DEPUY ORTHOPAEDICS INC US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention | UNK HIP ACETABULAR CUP DURALOC| UNKNOWN HIP ACETABULAR LINERS |