MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-08-03 for UNKNOWN BIOMET OSS BEARING N/A manufactured by Biomet Orthopedics.
[81691183]
(b)(4). Medical product: unknown oss femoral component, catalog # unknown lot # unknown, unknown oss assembly catalog# unknown, lot # unknown, unknown oss stem, catalog # unknown lot # unknown, unknown oss stem, catalog # unknown lot # unknown, unknown oss tibial tray, catalog # unknown lot # unknown, unknown palacos bone cement : catalog # unknown lot # unknown. Initial reporter: ben molenaers, nele arnout, johan bellemans? Complex total knee arthroplasty using resection prosthesis at mid-term follow-up? Department of orthopaedics and traumatology? The knee (2012) 550-554. (b)(4). The reported event was unable to be confirmed due to limited information received from the customer. A device history record review was unable to be performed as the lot number of the device involved in the event is unknown. A complaint history review was unable to be performed as the part and lot numbers are unknown. A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05577, 0001825034-2017-05578, 0001825034-2017-05579, 0001825034-2017-05580, 0001825034-2017-05581.
Patient Sequence No: 1, Text Type: N, H10
[81691184]
It was reported in a journal article that six (6) patients post operative final follow-up score was rated as poor.
Patient Sequence No: 1, Text Type: D, B5
[109915777]
This follow-up report is being submitted to relay additional information. Concomitant medical product: unknown oss femoral component, catalog # unknown lot # unknown ; unknown oss assembly catalog# unknown, lot # unknown ; unknown oss stem, catalog # unknown lot # unknown ; unknown oss stem, catalog # unknown lot # unknown ; unknown oss tibial tray, catalog # unknown lot # unknown ; unknown palacos bone cement : catalog # unknown lot # unknown ; unknown patella: catalog# unknown lot# unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05577 , 0001825034-2017-05578 , 0001825034-2017-05579 , 0001825034-2017-05580 , 0001825034-2017-05581, 0001825034-2017-06798, 0001825034-2017-06798. 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.
Patient Sequence No: 1, Text Type: N, H10
[109949802]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-05576 |
| MDR Report Key | 6762847 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-03 |
| Date of Report | 2017-08-30 |
| Date of Event | 2011-10-07 |
| Date Mfgr Received | 2017-08-02 |
| Date Added to Maude | 2017-08-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| 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 | UNKNOWN BIOMET OSS BEARING |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | JWY |
| Date Received | 2017-08-03 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2017-08-03 |