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 HEAD UNK HIP FEMORAL HEAD manufactured by Depuy Orthopaedics Inc Us.
[185953913]
(b)(4). Initial reporter occupation: lawyer. 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
[185953974]
After review of the medical records patient progress note dated (b)(6) 2018, reported of clicking about her left hip and significantly elevated metal levels. X-ray shows a fracture at the base of the clothespin part of the stem and loosening of the screw. Patient took a fall and since then experienced clicking. Both hips were metal on metal articulation. There was no left hip revision reported. Doi: (b)(6) 2009, dor: none reported, left hip. Please see (b)(4) for the right hip revision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09563 |
| MDR Report Key | 9897751 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN HIP FEMORAL HEAD |
| Generic Name | HIP FEMORAL HEAD |
| Product Code | KWY |
| Date Received | 2020-03-30 |
| Catalog Number | UNK HIP FEMORAL HEAD |
| 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 |