MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2017-12-28 for PINNACLE MTL INS NEUT36IDX54OD 121887354 manufactured by Depuy International Ltd - 8010379.
[95904291]
(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
[95904292]
Pinnacle revision left hip reason for revision: na. Doi: (b)(6) 2009: dor: (b)(6) 2016 (left hip).
Patient Sequence No: 1, Text Type: D, B5
[112499657]
Patient Sequence No: 1, Text Type: N, H10
[112499658]
After review of medical records for mdr reportability it was reported that the patient was revised to address pain and metal poisoning. Operative notes stated, there was a small amount of fluid, there was no metallosis staining, no signs of osteolysis. The acetabulum components were very well fixed. On the letter included on the attachments, it was reported that the patient's blood results showed elevated cobalt and chromium levels which were varying between the 70nmol and 90nmol. Radiograph shows soft tissue reactions without much marrow edema within the bone, her x-ray has excluded any significant bony problems. Patient has been having problem in terms of joint clicking in and out and pain all around the joint.
Patient Sequence No: 1, Text Type: D, B5
[120297450]
(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 will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2017-52574 |
| MDR Report Key | 7150595 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2017-12-28 |
| Date of Report | 2017-12-04 |
| Date of Event | 2016-06-02 |
| Date Mfgr Received | 2018-08-02 |
| Device Manufacturer Date | 2009-03-06 |
| Date Added to Maude | 2017-12-28 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY INT'L LTD. 8010379 |
| Manufacturer Street | LEEDS |
| 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 | PINNACLE MTL INS NEUT36IDX54OD |
| Generic Name | HIP METAL ACETABULAR LINERS |
| Product Code | OVO |
| Date Received | 2017-12-28 |
| Catalog Number | 121887354 |
| Lot Number | 2857617 |
| 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 ROAD LEEDS LS118DT UK LS11 8DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-28 |