MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-12 for UNKNOWN OXFORD TIBIAL COMPONENT N/A UNK OXFORD TIBIAL COMPONENT manufactured by Biomet Uk Ltd..
[178747691]
(b)(4). Initial report. Once the investigation has been completed, a supplemental mdr will be submitted. Concomitant medical products: medical product: unknown oxford femoral component, catalog #: unknown, lot #: unknown, medical product: unknown oxford bearing, catalog #: unknown, lot #: unknown. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00076, 3002806535-2020-00075. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[178747692]
It was reported that a patient underwent an initial right knee arthroplasty. Subsequently, a revision procedure was performed due to pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2020-00077 |
| MDR Report Key | 9699175 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-12 |
| 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 UK LTD. |
| Manufacturer Street | WATERTON INDUSTRIAL ESTATES |
| Manufacturer City | BRIDGEND CF313XA |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF31 3XA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN OXFORD TIBIAL COMPONENT |
| Generic Name | KNEE PROTHESIS |
| Product Code | NRA |
| Date Received | 2020-02-12 |
| Model Number | N/A |
| Catalog Number | UNK OXFORD TIBIAL COMPONENT |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET UK LTD. |
| Manufacturer Address | WATERTON INDUSTRIAL ESTATES BRIDGEND CF313XA UK CF31 3XA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-12 |