MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-08-31 for AGC DA 2000 TIBIAL TRAY 67MM N/A 154812 manufactured by Biomet Uk Ltd..
[84243850]
(b)(4). Udi (b)(4). Report source, foreign. The event occurred in (b)(6). It was initially reported the device would be returned and the evaluation is therefore anticipated. However, the device was not returned for evaluation at this time. Multiple mdr reports were filed for this event. Please see reports: 3002806535 - 2017 - 00877, 3002806535 - 2017 - 00878. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[84243851]
It was reported that a patient had an allergic reaction to nickel and has felt pain since the implantation of the prosthesis with abnormal stiffness. Suspicion of allergy to a prosthesis component, renewal of allergological test resulting in revision. No further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2017-00877 |
| MDR Report Key | 6834590 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-31 |
| Date of Report | 2018-05-23 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2018-05-22 |
| Device Manufacturer Date | 2015-03-23 |
| Date Added to Maude | 2017-08-31 |
| 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 | AGC DA 2000 TIBIAL TRAY 67MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | KRP |
| Date Received | 2017-08-31 |
| Model Number | N/A |
| Catalog Number | 154812 |
| Lot Number | 3528605 |
| ID Number | SEE H10 NARRATIVE |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-08-31 |