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 2018-05-04 for COMPLETE ULTAMET MTL 36IDX52OD 121887552 manufactured by Depuy Orthopaedics, Inc. 1818910?.
[107323307]
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
[107323308]
Patient was revised local tissue response and dislocation following mom hip arthroplasty from 2005. Patient consequence? Yes. Patient consequence description: local adverse tissue response. Action taken for procedure: head-liner exchange and soft tissue debridement. Is the information being submitted for this complaint all the details that are known/available regarding this event? Yes.
Patient Sequence No: 1, Text Type: D, B5
[119580949]
Investigation summary: no device associated with this report was received for examination. 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. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will 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
| Report Number | 1818910-2018-58878 |
| MDR Report Key | 7486270 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-04 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-08-14 |
| Date Added to Maude | 2018-05-04 |
| 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 | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY INTERNATIONAL LTD. 8010379 |
| Manufacturer Street | ST. ANTHONY'S RD |
| Manufacturer City | LEEDS LS118 DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8 DT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPLETE ULTAMET MTL 36IDX52OD |
| Generic Name | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS |
| Product Code | OVO |
| Date Received | 2018-05-04 |
| Catalog Number | 121887552 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. 1818910? |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-04 |