RHK 12 X 80 CEMENTED STEM
Report
- Report Number
- 3002806535-2022-00306
- Event Type
- Injury
- Date Received
- July 15, 2022
- Date of Event
- May 10, 2022
- Report Date
- August 29, 2022
- Manufacturer
- BIOMET UK LTD.
- Product Code
- JWH
- UDI-DI
- 05019279751976
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). (B)(6). INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10. ITEM NAME: RHK 12X80 CEMENTED STEM ITEM#: 159405 LOT#: 2084361. ITEM NAME: BIOMET TIB BLOCK 6MM 63 ITEM#: 141741 LOT#: 639830. ITEM NAME: BIOMET TIB BLOCK 6MM 63 ITEM#: 141741 LOT#: 203910 . ITEM NAME: VNGD SSKPSC TIB BRG S 12X63/67 ITEM#: 183822 LOT#: 486500. ITEM NAME: AGC MOD TIB LOCKING SCREW ITEM#: 153103 LOT#: 089550. ITEM NAME: OFFSET TIB TRAY 5.0MM ADAPTOR ITEM#:141491 LOT#: 551170. ITEM NAME: BIOMET OFFSET TIBIAL TRAY 63MM ITEM#: 141481 LOT#: 640750. ITEM NAME: VNGD DIST FEM AUG 60X5 RL/LM ITEM#: 184102 LOT#: 558410. ITEM NAME: VNGD DIST FEM AUG 60X5 LL/RM ITEM#:184122 LOT#: 346530. ITEM NAME: VNGD SSK PSC INTLK FMRL 60 RT ITEM#: 183302 LOT#: 667480. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/ RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. THE SURGICAL REPORT DETAILS THE METHODS OF EXTRACTION TO DETACH THE TIBIAL COMPONENT FROM THE CEMENT. THE REPORT FARTHER NOTES DIFFICULTY IN REMOVING THE DEVICE, WHICH LED TO THE FRACTURE OF THIS IMPLANT DURING THE REMOVAL. OVERALL FIT AND ALIGNMENT OF THE IMPLANTS WAS FOUND APPROPRIATE IN 2014 BUT IN 2022 STUDY SUGGESTED LOOSENING. RADIOLUCENCY AT THE BONE CEMENT INTERFACE AND WORSENING OSTEOPENIA MAY HAVE LED TO LOOSENING OF THE COMPONENTS WHICH LIKELY LED TO THE REVISION SURGERY. FINDINGS FROM ADDITIONAL INFORMATION HAVE NO IMPACT TO ORIGINAL EVALUATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING THAT COULD BE RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 DURING REMOVAL OF THE TIBIAL COMPONENT, THE TIBIAL PLATEAU BROKE OFF FROM THE STEM. TWO HOLES HAD TO BE DRILLED INTO THE PROSTHESIS TO REMOVE THE STEM FROM THE BONE. DAMAGE TO THE BONE OCCURRED WHILE REMOVING THE STEM. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2349712 | RHK 12 X 80 CEMENTED STEM | KNEE PROSTHESIS | JWH | BIOMET UK LTD. | N/A | 2084361 | 05019279751976 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Female | Hospitalization| R |