G7 BISPHERICAL SHELL 62H
Report
- Report Number
- 3002806535-2021-00386
- Event Type
- Injury
- Date Received
- September 13, 2021
- Date of Event
- September 6, 2021
- Report Date
- November 29, 2021
- Manufacturer
- BIOMET UK LTD.
- Product Code
- JDI
- UDI-DI
- 05019279515745
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT RETURNED HAS BEEN RETURNED FOR EVALUATION. THE LINER AND HEAD HAVE BEEN RETURNED WITH G7 SHELL. ASSOCIATED PRODUCTS: ASSOCIATED ITEM NUMBER 010000852. ITEM NAME G7 NEUTRAL E1 LINER 32MM H. LOT # 3973281. ASSOCIATED ITEM NUMBER 650-0834. ITEM NAME DELTA CER FEM HD 032/0MM 12/14. LOT # UNKNOWN. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
CMP-(B)(4). G7 BISPHERICAL ACETABULAR SHELL, A BIOLOX DELTA FEMORAL HEAD AND A G7 E1 LINER WERE SENT TO THE RESEARCH DEPARTMENT FOR EVALUATION, AFTER THEPARTS WERE REVISED DUE TO LOOSENING OF THE ACETABULAR SHELL AFTER APPROXIMATELY 2 YEARS AND 10 MONTHS IN SERVICE. THE G7 BISPHERICAL ACETABULAR SHELL IS SHOWN AS RECEIVED WITH CMP-(B)(4)., WITH THE E1 LINER STILL ASSEMBLED. THE OUTER SURFACE OF THE SHELL SHOWED NO SIGNS OF BONE TISSUE INTEGRATION, AS REPORTED IN THE COMPLAINT DESCRIPTION. SOME OF THE TEETH ON THE OUTER SURFACE OF THE SHELL APPEARED SLIGHTLY DAMAGED, WHICH MAY HAVE BEEN CAUSED BY INSTRUMENTS DURING REVISION. SOME OTHER TEETH APPEARED POLISHED OR BURNISHED, WHICH MAY ALSO HAVE BEEN CAUSED BY INSTRUMENTS USED DURING REVISION OR BY THE RELATIVE MOVEMENT OF THE COMPONENT WITH THE PATIENT¿S BONE, THUS FURTHER CONFIRMING THE COMPONENT LOOSENING. MINOR SCRATCHES, LIKELY CAUSED BY INSTRUMENTS, AND DISCOLOURATION OF THE ANODIZED RIM OF THE ACETABULAR SHELL IS EVIDENT. VISUAL EXAMINATION OF THE RETURNED G7 BISPHERICAL SHELL, INCLINATION ANGLE MEASUREMENTS FROM THE PROVIDED RADIOGRAPHS AND INFORMATION PROVIDED IN THE REVISION SURGERY NOTES CONFIRM THE REPORTED LOOSENING OF THE COMPONENT AND LACK OF BONE INTEGRATION. THE ROOT CAUSE OF THIS CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION, HOWEVER THE SUBOPTIMAL BONY COVERAGE OF THE COMPONENT MAY HAVE BEEN A CONTRIBUTING FACTOR. THE MANUFACTURING HISTORY RECORDS OF THE RECEIVED COMPONENTS AND ASSOCIATED GTS FEMORAL STEM HAVE BEEN CHECKED AND VERIFY THAT THESE PARTS WERE MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. THE PARTS WERE MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS DATABASE SHOWS THAT WE HAVE RECEIVED NO REPORTED EVENTS FOR REVISION DUE TO LOOSENING FOR THE SAME ITEM NUMBER PRIOR TO THE REPORTED EVENT. THE SEVERITY OF THE REPORTED EVENT FOR SIMILAR COMPLAINTS ARE IN LINE WITH THE RISK FILE. INVESTIGATION IS COMPLETED BASED ON CURRENT AVAILABLE INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND FURTHER INVESTIGATED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT RETURNED HAS BEEN RETURNED FOR EVALUATION. THE LINER AND HEAD HAVE BEEN RETURNED WITH G7 SHELL. ASSOCIATED PRODUCTS: ASSOCIATED ITEM NUMBER 010000852. ITEM NAME G7 NEUTRAL E1 LINER 32MM H. LOT # 3973281. ASSOCIATED ITEM NUMBER 650-0834. ITEM NAME DELTA CER FEM HD 032/0MM 12/14. LOT # UNKNOWN. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2018. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION OF THE CUP DUE TO LOOSENING ON (B)(6) 2021.
IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2018. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION OF THE CUP DUE TO LOOSENING, NO BONE IN GROWTH OF THE CUP ON (B)(6) 2021.
IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2018. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION OF THE CUP DUE TO LOOSENING ON (B)(6) 2021.
INITIAL REPORT: (B)(4). REPORT SOURCE, FOREIGN : EVENT OCCURRED IN THE (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2018. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION OF THE CUP DUE TO LOOSENING ON (B)(6) 2021. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1356524 | G7 BISPHERICAL SHELL 62H | STERILE TOTAL HIP ARTHROPLASTY | JDI | BIOMET UK LTD. | N/A | 3320291 | 05019279515745 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Hospitalization| R |