MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-03-30 for ATTUNE CR RP INSRT SZ 7 5MM 1516-30-705 151630705 manufactured by Depuy Ireland - 9616671.
[188873199]
(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
[188873200]
Subject id: (b)(6). Study: dots. Clinical notification received for revision of right total knee to address dislocation/subluxation. Date of implantation: (b)(6) 2019; date of revision: (b)(6) 2019; (right knee). Treatment: i&d and revision poly exchange.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09626 |
| MDR Report Key | 9900481 |
| Report Source | STUDY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-07-23 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2018-10-28 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY IRELAND - 9616671 |
| Manufacturer Street | LOUGHBEG, RINGASKIDDY CO |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTUNE CR RP INSRT SZ 7 5MM |
| Generic Name | ATTUNE IMPLANT : KNEE TIBIAL INSERT |
| Product Code | NJL |
| Date Received | 2020-03-30 |
| Model Number | 1516-30-705 |
| Catalog Number | 151630705 |
| Lot Number | 8945103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |