SULOX¿¢, HEAD, S, ø 32/-3.5, TAPER 12/14
Report
- Report Number
- 0009613350-2024-00424
- Event Type
- Injury
- Date Received
- September 3, 2024
- Date of Event
- August 12, 2024
- Report Date
- January 17, 2025
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- UDI-DI
- 00889024416970
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10. DURASUL®, ALPHA INSERT, II/32 ITEM# (B)(4). LOT# 2953655. G2. REPORT SOURCE: GERMANY. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D10. DURASUL®, ALPHA INSERT, II/32 ITEM# 0100013409 LOT# 2953655. ALLOFIT ALLOCLAS SHELL 52/II ITEM# 4245 LOT# 2958226. CLS STEM 135DEG 11.25 12/14 ITEM# 290039112 LOT# 2945316.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D10. DURASUL®, ALPHA INSERT, II/32 ITEM# 0100013409 LOT# 2953655. ALLOFIT ALLOCLAS SHELL 52/II ITEM# 4245 LOT# 2958226. CLS STEM 135DEG 11.25 12/14 ITEM# 290039112 LOT# 2943963. THE REPORTED PRODUCT AS WELL AS THE ASSOCIATED LINER WERE RETURNED TO THE POST MARKET SURVEILLANCE TEAM FOR EXAMINATION. THE CERAMIC FEMORAL HEAD HAS FRACTURED INTO SIX FRAGMENTS. THE ARTICULATION SURFACES, FRACTURE SURFACES AS WELL AS THE TAPER CONNECTION SHOW SEVERAL METALLIC SMEARING. THE LINER SHOWS NOTABLE SIGNS OF WEAR/ABRASION, ESPECIALLY ON THE ARTICULATING SURFACE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. IT WAS REPORTED THAT THE PATIENT FELT PAIN AFTER THE FALL EVENT AND THEREAFTER WENT TO THE EMERGENCY DEPARTMENT. HOWEVER, IF THE FALL EVENT POTENTIALLY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT 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 A PATIENT EXPERIENCED AN INITIAL TOTAL HIP REPLACEMENT AND APPROXIMATELY 6 YEARS POST IMPLANTATION UNDERWENT A REVISION SURGERY DUE TO FRACTURED CERAMIC HEAD AFTER FALLING OFF OF HIS BIKE. DURING THE REVISION CUP WAS NOTED TO BE WELL FIXED. THE FEMORAL HEAD AND INLAY WERE EXCHANGED WITHOUT COMPLICATIONS. DILIGENCE IS COMPLETED AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
DILIGENCE IS COMPLETED AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
DILIGENCE IS COMPLETED AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 899815 | SULOX¿¢, HEAD, S, ø 32/-3.5, TAPER 12/14 | PROSTHESIS, HIP | LZO | ZIMMER GMBH | N/A | 2943963 | 00889024416970 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Required Intervention| H | SEE H11 NARRATIVE.| SEE H11 NARRATIVE.| SEE H11 NARRATIVE. |