MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-30 for UNKNOWN HIP FEMORAL STEM UNK HIP FEMORAL STEM manufactured by Depuy Orthopaedics Inc Us.
[186790356]
(b)(4). No device associated with this report was received for examination. A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided. The information received will be retained for trend analysis, post market surveillance, or other events within the quality system. Initial reporter occupation: lawyer. (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
[186790357]
Asr hip mom litigation record received. The litigation alleges severe pain, elevated ions level, loss of wages past and future, trouble sleeping and walking, emotional distress, and other illness and injuries. Asr hip implant was revised due to elevated levels of cobalt and chromium ions, metallosis, adverse reaction to metal debris. Revision operative note mentioned of synovitis and inflammatory tissue. Doi: (b)(6) 2009; dor: (b)(6) 2018 (left hip).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09560 |
| MDR Report Key | 9897461 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-11 |
| Date of Event | 2018-12-22 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-30 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1749/1816-2011 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN HIP FEMORAL STEM |
| Generic Name | HIP FEMORAL STEM |
| Product Code | KWY |
| Date Received | 2020-03-30 |
| Catalog Number | UNK HIP FEMORAL STEM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-30 |