MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for HIP BA BIO 28MM 12/14 + 5 9111122 manufactured by Depuy International Ltd - 8010379.
[186750571]
(b)(4). The devices were reviewed by bioengineering and a report was received stating it is unlikely that a potential product issue was present. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. 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
[186750572]
Revision of hip-tep (inlay and head) left side as pe inlay disassociated from the cup. The head caused metal wear at the inner side of the pinnacle cup. Doi: unknown, dor: (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09464 |
| MDR Report Key | 9889211 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-03-11 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2018-12-31 |
| 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 |
| 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 ORTHOPEDICS DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | CORK MFG & MATERIAL WAREHOUSE |
| Manufacturer Street | LOUGHBEG RINGASKIDDY |
| Manufacturer City | CORK |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIP BA BIO 28MM 12/14 + 5 |
| Generic Name | ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS |
| Product Code | KWY |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2019-04-08 |
| Catalog Number | 9111122 |
| Lot Number | 9005716 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY INTERNATIONAL LTD - 8010379 |
| Manufacturer Address | ST. ANTHONY'S ROAD LEEDS LS118DT UK LS11 8DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |