AVANTAGE E1 INLAY S56 / 28
Report
- Report Number
- 3006946279-2022-00103
- Event Type
- Injury
- Date Received
- October 20, 2022
- Date of Event
- October 5, 2022
- Report Date
- January 23, 2023
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Product Code
- LPH
- UDI-DI
- 00887868524998
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CONCOMITANT MEDICAL DEVICES: VERSYS FEMORAL HEAD 28MM/-3.5. ITEM# 8018-28-01, LOT# 65270511. FOREIGN SOURCE: SOUTH AFRICA. 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 AND/OR CORRECTED INFORMATION. H6, TYPE OF INVESTIGATION- CORRECTED. THE PRODUCT WAS RETURNED, LAB ANALYSIS WAS PERFORMED. PERFORMED A VISUAL INSPECTION OF THE RETURNED ITEM. THE ITEM/LOT INFORMATION COULD BE VERIFIED AS THERE ARE NO PRODUCT MARKINGS ON THE INLAY. THERE WERE SEVERAL NICKS AND GOUGES ON THE ITEM ITSELF ALONG WITH ONE LOCATION THAT LOOKS LIKE IT MAY HAVE BEEN CUT. THE DISLOCATION CANNOT BE CONFIRMED WITH THE INSPECTION OF THE PART. X-RAYS WERE REVIEWED AND SHOW THAT THE FEMORAL HEAD IS NOT CONFIRMED TO BE LUCENT, AS IT DOES APPEAR TO REMAIN ALIGNED WITH THE REMAINDER OF THE FEMORAL COMPONENT DESPITE ITS ECCENTRIC POSITIONING WITH RESPECT TO THE ACETABULAR CUP. INTERVAL DEVELOPMENT OF ABNORMAL ALIGNMENT BETWEEN THE FEMORAL AND ACETABULAR HARDWARE COMPONENTS NOTED ON THE PRE REVISION IMAGED. THE EXACT CAUSE OF THIS FINDING IS NOT DETERMINED RADIOGRAPHICALLY. THIS CAN BE SEEN WITH DISRUPTION OF THE POLYETHYLENE LINING OF THE ACETABULAR CUP, BUT THIS IS NOT CONFIRMED AND DOES NOT APPEAR TO ACCOUNT FOR THE FINDINGS DESCRIBED IN THE EVENT/DEFICIENCY DESCRIPTION. NO PROBLEM WAS FOUND WITH THE DEVICE AFTER REVIEW BY A HCP, THE STRAINED ANKLE WAS DETERMINED TO CAUSE THE FALL AND SUBSEQUENTLY THE DISLOCATION. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. PRODUCT WAS NOT RETURNED, OR PICTURES NOT PROVIDED. DEVICE EVALUATION COULD NOT BE PERFORMED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THIS DEVICE IS USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 FOUR MONTHS POST PRIMARY HIP REPLACEMENT, THE PATIENT HAD A FALL AND HEARD A CLICKING SOUND IN HIS HIP. UPON X-RAYS IT WAS FOUND THAT THE LEFT HIP HAD DISLOCATED AND THE PATIENT UNDERWENT A REVISION SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED YET.
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 |
|---|---|---|---|---|---|---|---|
| 1986807 | AVANTAGE E1 INLAY S56 / 28 | HIP PROSTHESIS | LPH | BIOMET FRANCE S.A.R.L. | N/A | 0001506720 | 00887868524998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Hospitalization| R |