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 2018-02-16 for PINNACLE MTL INS NEUT28IDX48OD 121889148 manufactured by Depuy International Ltd. 8010379.
[100255122]
(b)(4). 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
[100255123]
Clinical adverse event received for infection - deep. Event is serious and is considered severe. Event is has a remote possibility of being related to device and is definitely not related to procedure. Treatment includes irrigation and debridement as well as revision of the head and liner. Doi: (b)(6) 2002. Doe: (b)(6) 2018. Dor: (b)(6) 2018 (right hip).
Patient Sequence No: 1, Text Type: D, B5
[110484904]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119067397]
Product complaint # :(b)(4). 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, a follow-up medwatch will be filed as appropriate.?
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2018-53528 |
| MDR Report Key | 7276461 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-16 |
| Date of Report | 2018-01-23 |
| Date of Event | 2018-01-20 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-02-16 |
| 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 IN 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 | PINNACLE MTL INS NEUT28IDX48OD |
| Generic Name | HIP METAL ACETABULAR LINERS |
| Product Code | OVO |
| Date Received | 2018-02-16 |
| Catalog Number | 121889148 |
| Lot Number | XNA-53 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY INTERNATIONAL LTD. 8010379 |
| Manufacturer Address | ST. ANTHONY'S RD LEEDS IN LS118 DT UK LS11 8 DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-16 |