MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-27 for ATTUNE RP TIB BASE SZ 5 CEM 1506-10-005 150610005 manufactured by Depuy Ireland - 9616671.
[185952662]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Initial reporter occupation: legal.
Patient Sequence No: 1, Text Type: N, H10
[185952663]
Patient received an attune total knee to treat severe osteoarthritis of the left knee. Patella was resurfaced, and competitor cement was utilized. The procedure was completed without complications. Records indicate the patient received a revision due to pain. Upon entering the knee, the surgeon noted the tibial tray was loose at the cement to implant interface. The femoral component and patella were well-fixed and retained. There was no reported product problem with the explanted tibial insert. The patient was implanted with a depuy revision knee utilizing unknown cement. The procedure was completed without complications. Doi: (b)(6) 2015, dor: (b)(6) 2019, left knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09491 |
| MDR Report Key | 9890521 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2015-08-17 |
| Date Added to Maude | 2020-03-27 |
| 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 CO. |
| 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 5 CEM |
| Generic Name | ATTUNE IMPLANT : KNEE TIBIAL TRAY |
| Product Code | NJL |
| Date Received | 2020-03-27 |
| Model Number | 1506-10-005 |
| Catalog Number | 150610005 |
| Lot Number | 8162676 |
| 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 | 2020-03-27 |