MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-25 for ATTUNE RP TIB BASE SZ 4 CEM 1506-10-004 150610004 manufactured by Depuy Ireland - 9616671.
[188207156]
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4). Initial reporter occupation: lawyer.
Patient Sequence No: 1, Text Type: N, H10
[188207157]
The patient received a left revision on (b)(6) 2019 to treat pain and instability. Upon entering the knee, the surgeon encountered and excised scar tissue. The tibial tray was grossly loose at the cement to implant interface. Doi: (b)(6) 2016. Dor: (b)(6) 2019; left knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09232 |
| MDR Report Key | 9879904 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-05-21 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2016-07-25 |
| Date Added to Maude | 2020-03-25 |
| 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 | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY IRELAND - 9616671 |
| Manufacturer Street | LOUGHBEG RINGASKIDDY |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTUNE RP TIB BASE SZ 4 CEM |
| Generic Name | ATTUNE IMPLANT : KNEE TIBIAL TRAY |
| Product Code | NJL |
| Date Received | 2020-03-25 |
| Model Number | 1506-10-004 |
| Catalog Number | 150610004 |
| Lot Number | 8345281 |
| 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 | 2020-03-25 |