MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for ATTUNE MEDIAL DOME PAT 29MM 1518-20-029 151820029 manufactured by Depuy Ireland - 9616671.
[185893119]
(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
[185893120]
It was reported that the sales rep was notified that the patient had an infected left knee. The surgical removal of implants was planned for on an urgent basis on this day. Surgery was performed implants were removed and a prostalac knee spacer was implanted. Doi: (b)(6) 2018, (b)(6) 2019 (insert). Dor: (b)(6) 2020, left knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09803 |
| MDR Report Key | 9907895 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2017-07-19 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| 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 MEDIAL DOME PAT 29MM |
| Generic Name | ATTUNE IMPLANT : KNEE PATELLA |
| Product Code | JWH |
| Date Received | 2020-03-31 |
| Model Number | 1518-20-029 |
| Catalog Number | 151820029 |
| Lot Number | 8583168 |
| 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 | 2020-03-31 |