CER BIOLOXD OPTION HD 36MM
Report
- Report Number
- 3002806535-2024-00011
- Event Type
- Injury
- Date Received
- January 9, 2024
- Date of Event
- August 30, 2023
- Report Date
- March 6, 2024
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LZO
- UDI-DI
- 00880304521957
- PMA / PMN Number
- K192683
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2024-00012-2. THE PRODUCTS REMAIN IMPLANTED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED AN ANATOMIC ALIGNMENT OF THE RIGHT HIP ARTHROPLASTY WITHOUT CHANGE IN IMPLANT POSITION FROM THE 6 MONTH POST OP THROUGH 5 YEAR POST OP IMAGES. NO CAUSE FOR TENDINITIS IS IDENTIFIED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS OF EVENT. PATIENT RECEIVED SEVERAL COSRTISONE INJECTION BUT CONTINUES TO HAVE PAIN WITH ACTIVE HIP FLEXION WHICH IS ALLEVIATED WITH REST. DEVICE IS USED FOR TREATMENT. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT 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.
(B)(4). D10 - ASSOCIATED MEDICAL DEVICES: CER OPTION TYPE 1 TPR SLEVE -6; ITEM# 650-1064; LOT# 2912967. TPRLC 133 T1 PPS HO 11X142MM; ITEM# 51-104110; LOT# 6232281. G7 FINNED 4 HOLE SHELL 56F; ITEM# 110017105; LOT# 6215509. G7 NEUTRAL E1 LINER 36MM F; ITEM# 010000858; LOT# 6292613 . MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2024-00012. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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 CORRECTED INFORMATION. B3: THE EVENT DATE WAS CORRECTED FROM (B)(6) 2023. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT DURING A CLINICAL STUDY, AT THE 5-YEAR FOLLOW-UP APPOINTMENT, THE PATIENT WAS EXPERIENCING PAIN, DIFFICULTY WITH AMBULATION AND COMPLETING DAILY ACTIVITIES; AND WAS DIAGNOSED WITH TENDONITIS. THE PATIENT WAS TREATED WITH ANTI-INFLAMMATORY MEDICATION, PHYSICAL THERAPY, AND A STEROID INJECTION. THE ISSUE HAS BEEN CONSIDERED RESOLVED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
IT WAS REPORTED THAT DURING A CLINICAL STUDY, AT THE 5-YEAR FOLLOW-UP APPOINTMENT, THE PATIENT WAS EXPERIENCING PAIN, DIFFICULTY WITH AMBULATION AND COMPLETING DAILY ACTIVITIES; AND WAS DIAGNOSED WITH TENDONITIS. THE PATIENT WAS TREATED WITH ANTI-INFLAMMATORY MEDICATION, PHYSICAL THERAPY, AND A STEROID INJECTION. THE ISSUE WAS CONSIDERED RESOLVED. THREE-MONTHS LATER, IN A FOLLOW-UP APPOINTMENT, THE PATIENT NOTED TEMPORARY RELIEF FROM THE INJECTION BUT IS STILL EXPERIENCING PAIN DURING ACTIVE FLEXION OR ACTIVITY. THE PATIENT IS MAINTAINING CONSERVATIVE TREATMENT MODALITIES AND PHYSICAL THERAPY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 605131 | CER BIOLOXD OPTION HD 36MM | HIP PROSTHESIS | LZO | BIOMET UK LTD. | 2934974 | 00880304521957 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention| H |