BIOMET BONE CEMENT R 1X40 US
Report
- Report Number
- 3006946279-2022-00011
- Event Type
- Injury
- Date Received
- January 28, 2022
- Date of Event
- November 12, 2021
- Report Date
- February 18, 2022
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Product Code
- LOD
- UDI-DI
- 00887868214578
- PMA / PMN Number
- K172408
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). LIST OF ASSOCIATED DEVICES: BIOMET BONE CEMENT R 1X40 US, REFERENCE 110035368, BATCH 826AAC2203. OFFSET TIB TRAY 2.5MM ADAPTOR, REFERENCE (B)(4), BATCH 752210. SERIES A PAT STD 31 3 PEG, REFERENCE (B)(4), BATCH 674220. VNGD TI FEM SSK 70MM RT, REFERENCE (B)(4), BATCH 486890. BMT SPLINED KNEE STM 18X120, REFERENCE (B)(4), BATCH 082360. BIOMET OFFSET TIBIAL TRAY 71MM, REFERENCE (B)(4), BATCH 154000. BMT SPLINED KNEE STM 80X16MM, REFERENCE (B)(4), BATCH 901020. VNGD SSK PSC TIB BRG 10X71/75, REFERENCE (B)(4), BATCH 740600. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. HOSPITAL X-RAY INTERPRETATION HAS BEEN RECEIVED AND STATES THAT THERE IS 2 MM LUCENCY ABOUT THE BONE CEMENT INTERFACE ADJACENT TO THE MEDIAL PLATE COMPONENT OF THE PROXIMAL TIBIAL HARDWARE. MOREOVER, THE X-RAYS HAVE BEEN RECEIVED AND ANALYZED BY MEDICAL METRICS INC. THAT STATES THAT THERE IS A POSSIBLE HYPERDENSITY WITHIN THE POSTERIOR JOINT SPACE WHICH COULD INDICATE UNDERLYING METALLOSIS. FINALLY, COMPLAINT DESCRIPTION STATES THAT A LARGE AMOUNTS OF METAL DEBRIS WERE FOUND DURING REVISION SURGERY, WHICH COULD EXPLAIN THE LOOSENING. THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A COMPLAINT EXTRACT WAS DONE REGARDING REVISION DUE TO LOOSENING, PAIN AND METALLOSIS: 4 COMPLAINTS (5 PRODUCTS), THIS ONE INCLUDED, HAVE BEEN RECORDED ON BIOMET BONE CEMENT R 1X40, REFERENCE 110035368, FROM JANUARY 01, 2019 TO FEBRUARY 16, 2022. 1 COMPLAINTS (1 PRODUCTS), THIS ONE INCLUDED, HAVE BEEN RECORDED ON BIOMET BONE CEMENT R 1X40, REFERENCE 110035368, BATCH 743CAH1407. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE LOOSENING COULD BE THE METALLOSIS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (B)(6) 2019. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, SWELLING, COULDN'T STRAIGHTEN LEG, COULDN'T WALK WITHOUT FALLING DOWN, COULDN'T USE LEG, WEIGHT GAIN, BECAME DIABETIC AND HAD LOOSENING OF THE IMPLANT. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021 WHERE LARGE AMOUNTS OF METAL DEBRIS WERE FOUND.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (B)(6) 2019. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, SWELLING, COULDN'T STRAIGHTEN LEG, COULDN'T WALK WITHOUT FALLING DOWN, COULDN'T USE LEG, WEIGHT GAIN, BECAME DIABETIC AND LOOSENING OF THE HARDWARE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021 WHERE LARGE AMOUNTS OF METAL DEBRIS WERE FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591794 | BIOMET BONE CEMENT R 1X40 US | BONE CEMENT | LOD | BIOMET FRANCE S.A.R.L. | 110035368 | 743CAH1407 | 00887868214578 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | Required Intervention |