G7 BISPHERICAL SHELL 52E
Report
- Report Number
- 3002806535-2024-00383
- Event Type
- Injury
- Date Received
- September 24, 2024
- Date of Event
- August 27, 2024
- Report Date
- April 9, 2025
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LPH
- UDI-DI
- 05019279515691
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10 ¿ 650-0337 TPRLC COCR 7.5X135MM 12/14 LOT # 6817862. 650-0667 DELTA CER FM HD 036/+8MM 12/14 LOT # 2020030591. 010000857 G7 NEUTRAL E1 LINER 36MM E 6515637. G2 ¿ FOREIGN ¿ GERMANY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K101336. THE CUP WAS RETURNED FOR INVESTIGATION TOGETHER WITH THE LINER. NO BONE ON GROWTH CAN BE SEEN ON THE ANCHORING SURFACE OF THE CUP; SOME OF THE FEATURES ON THE ANCHORING SURFACE SHOW DAMAGES IN THE FORM OF DENTS AND SOME SCRATCHES ARE VISIBLE ON THE RIM. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. FOUR RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. AN AP PELVIS OVERVIEW TAKEN AFTER INITIAL SURGERY SHOWS A LEFT TOTAL HIP ARTHROPLASTY WITH NO RADIOLUCENCY AND A NORMAL APPEARANCE OF THE MEDIAL WALL OF THE LEFT ACETABULUM; MILD DEGENERATIVE CHANGES OF THE VISUALIZED SI JOINT, SYMPHYSIS PUBIS AND RIGHT HIP WERE NOTED. AN AP PELVIS OVERVIEW TAKEN BEFORE REVISION SURGERY DEMONSTRATES A LEFT TOTAL HIP ARTHROPLASTY WITH POSSIBLE FRACTURE OF THE MEDIAL WALL OF THE ACETABULUM AND ACETABULAR PROTRUSION. THERE IS AN ASSOCIATED CHANGE IN THE POSITION OF THE ACETABULAR CUP. NO DEFINITE RADIOLUCENCY IS OBSERVED. OSTEOPENIA IS PRESENT. MILD DEGENERATIVE CHANGES ARE NOTED IN THE BILATERAL SACROILIAC JOINTS, SYMPHYSIS PUBIS, AND RIGHT HIP. BASED ON THE AVAILABLE RADIOGRAPHS, LOOSENING OF THE CUP CAN BE CONFIRMED HOWEVER BASED ON THE AVAILABLE INFORMATION THE CAUSE MAY BE MULTIFACTORIAL, CONSISTING OF PATIENT- AND PROCEDURE-RELATED FACTORS. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY FOUR YEARS AGO. SUBSEQUENTLY, THE PATIENT DEVELOPED LOOSENING OF THE CEMENTLESS CUP WITH MIGRATION AND PROTRUSION TO THE CRANIOMEDIAL ASPECT/LESSER PELVIS. POOR ACETABULAR BONE QUALITY/BONE DAMAGE WAS ALSO NOTED. REVISION OF THE CUP, LINER, AND HEAD OCCURRED TEN DAYS AGO WITHOUT COMPLICATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1877800 | G7 BISPHERICAL SHELL 52E | HIP PROSTHESIS | LPH | BIOMET UK LTD. | N/A | 6708738 | 05019279515691 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention| H | SEE H11 NARRATIVE. |