MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2017-03-16 for OXFORD PARTIAL KNEE SYSTEM DOMED LATERAL TIBIAL TRAY SIZE C 166553 manufactured by Biomet Uk Ltd..
[70139898]
(b)(4). Concomitant medical products - oxford domed lateral meniscal bearing, catalog: 161695, lot: 2363409; oxford femoral size medium, catalog: 154601, lot: 2599722. Customer has not indicated that the product will be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under pma number p010014. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-00143 and 3002806535-2017-00144.
Patient Sequence No: 1, Text Type: N, H10
[70139899]
It was reported that the patient underwent a knee revision procedure approximately four years post implantation due to pain. The patient was converted from a partial to a total knee prosthesis. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2017-00145 |
| MDR Report Key | 6411146 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2017-03-16 |
| Date of Report | 2017-03-16 |
| Date of Event | 2016-04-12 |
| Date Mfgr Received | 2017-02-14 |
| Device Manufacturer Date | 2012-07-03 |
| Date Added to Maude | 2017-03-16 |
| 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 | OXFORD PARTIAL KNEE SYSTEM DOMED LATERAL TIBIAL TRAY SIZE C |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | KRP |
| Date Received | 2017-03-16 |
| Catalog Number | 166553 |
| Lot Number | 2724490 |
| ID Number | SEE H10 NARRATIVE |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2017-03-16 |