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 2017-12-29 for PINNACLE MTL INS NEUT36IDX52OD 121887352 manufactured by Depuy Orthopaedics Inc Us.
[96021730]
Product complaint # (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
[96021731]
Left hip arthroplasty on (b)(6) 2011. In (b)(6) 2017 the patient was subjected to a revision surgery due difficulty in walking, feeling of instability. In addition high ions levels of cr and co were detected. Update (b)(6) 2017: claim notification, litigation and medical records of pinnacle received. In addition to what was previously alleged,claim letter alleges pain, noise(scratching and tearing) and bone erosion. (b)(6) 2011; (b)(6) 2017 (left hip) pinnacle.
Patient Sequence No: 1, Text Type: D, B5
[118573708]
Pc(b)(4). No device associated with this report was received for examination. Depuy considers the investigation closed at this time. 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 | 1818910-2017-52702 |
| MDR Report Key | 7153981 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2017-12-29 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-03-09 |
| Date Mfgr Received | 2018-08-07 |
| Device Manufacturer Date | 2010-02-22 |
| Date Added to Maude | 2017-12-29 |
| 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 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| 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 | PINNACLE MTL INS NEUT36IDX52OD |
| Generic Name | HIP METAL ACETABULAR LINERS |
| Product Code | OVO |
| Date Received | 2017-12-29 |
| Catalog Number | 121887352 |
| Lot Number | 3081064 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-29 |