MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-11 for MUNZEL 8X75MM TIB BEARING N/A PM102481 manufactured by Biomet Orthopedics.
[2660532]
It was reported that patient underwent custom knee arthroplasty in 1998. Subsequently, surgeon is recommending a revision procedure due to wear of the custom tibial bearing. No revision procedure has occurred to date.
Patient Sequence No: 1, Text Type: D, B5
[9878968]
Event date - no revision procedure has occurred to date. Implanted date - sometime in 1998. Explanted date - device remains implanted. Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. The tibial bearing has been implanted for approximately fourteen years.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00820 |
| MDR Report Key | 2606766 |
| Report Source | 07 |
| Date Received | 2012-06-11 |
| Date of Report | 2012-05-14 |
| Date Mfgr Received | 2012-05-14 |
| Device Manufacturer Date | 1998-05-16 |
| Date Added to Maude | 2012-06-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANGELA DICKSON |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MUNZEL 8X75MM TIB BEARING |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BSN |
| Date Received | 2012-06-11 |
| Model Number | N/A |
| Catalog Number | PM102481 |
| Lot Number | 203790 |
| ID Number | N/A |
| Device Expiration Date | 2003-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-06-11 |