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 2020-03-25 for ATTUNE PS RP INSRT SZ 5 10MM 1516-50-510 151650510 manufactured by Depuy Ireland - 9616671.
[186303764]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: no device associated with this report was received for examination. A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution. Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.
Patient Sequence No: 1, Text Type: N, H10
[186303765]
Clinical adverse event received for significant left patellar crepitus. Event is not serious and is considered moderate. Event is possibly related to device and definitely related to procedure. Date of implantation: (b)(6) 2018, date of event (onset): (b)(6) 2019, (left knee).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09217 |
| MDR Report Key | 9879003 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-08-21 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2017-03-19 |
| 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 |
| 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 PS RP INSRT SZ 5 10MM |
| Generic Name | ATTUNE IMPLANT : KNEE TIBIAL INSERT |
| Product Code | NJL |
| Date Received | 2020-03-25 |
| Model Number | 1516-50-510 |
| Catalog Number | 151650510 |
| Lot Number | 8491845 |
| 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 |