MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2018-07-19 for UNKNOWN KNEE TIBIAL TRAY UNK KNEE TIBIAL TRAY manufactured by Depuy Orthopaedics, Inc. 1818910.
[114466469]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[114466530]
(b)(6). Clinical database notification email received indicating revision due to aseptic loosening of the femoral and tibial component. Doi: not provided; dor: (b)(6) 2018; (left knee). Femoral, tibial and insert components revised. Cement manufacturer not provided.
Patient Sequence No: 1, Text Type: D, B5
[130235809]
Patient Sequence No: 1, Text Type: N, H10
[130666852]
Product complaint # : (b)(4). The implant associated with this report was not returned. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2018-64821 |
| MDR Report Key | 7703472 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2018-07-19 |
| Date of Report | 2018-06-25 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-12-05 |
| Date Added to Maude | 2018-07-19 |
| 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. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 19380XXXX |
| Manufacturer Country | US |
| Manufacturer Postal | 19380XXXX |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY INT'L LTD. 8010379 |
| Manufacturer Street | ST ANTHONYS ROAD |
| Manufacturer City | LEEDS IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN KNEE TIBIAL TRAY |
| Generic Name | KNEE TIBIAL TRAY |
| Product Code | JJW |
| Date Received | 2018-07-19 |
| Catalog Number | UNK KNEE TIBIAL TRAY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-19 |