MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-31 for ATTUNE PS FB INSRT SZ 4 6MM 1516-40-406 151640406 manufactured by Depuy Ireland - 9616671.
[187721834]
(b)(4). Initial reporter occupation: lawyer. 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
[187721835]
Patient received attune tka to treat severe end-stage osteoarthritis with varus of the right knee. The patella was resurfaced and depuy cement x 2 was utilized. The procedure was completed without complications. Records indicate the patient was revised due to pain, swelling, instability and progressive deformity. Preoperative radiographic imaging identified complete lucency around the tibial tray and with tibial varus alignment and varus collapse. Upon entering the knee, the surgeon identified and debrided capsular scar tissue and synovitis. A complete capsulotomy was performed. The tibial tray was grossly loose and was completely debonded t the cement to implant interface. Upon removal tibial tray, the surgeon discovered a tibial defect at the area of collapse. The femoral component and patella were well-fixed and retained. There was no reported product problem with the explanted tibial insert. The patient received depuy tibial revision products utilizing competitor cement. The procedure was completed without complications. Doi: (b)(6) 2014. Dor: (b)(6) 2019; right knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09703 |
| MDR Report Key | 9902650 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2013-10-14 |
| 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 |
| 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 | JTE RAYNHAM MFG SITE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTUNE PS FB INSRT SZ 4 6MM |
| Generic Name | ATTUNE IMPLANT : KNEE TIBIAL INSERT |
| Product Code | JWH |
| Date Received | 2020-03-31 |
| Model Number | 1516-40-406 |
| Catalog Number | 151640406 |
| Lot Number | 436603 |
| Device Expiration Date | 2018-09-30 |
| 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 |