MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-11 for UNKNOWN HIP FEMORAL HEAD UNK HIP FEMORAL HEAD manufactured by Depuy Orthopaedics Inc Us.
[183090168]
(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
[183090169]
After review of medical records patient was revised to addressed painful left total hip arthroplasty with metal on metal articulation and increased serum metal ions. Operatives notes indicated small amount of black corrosion on the trunnion, noted some small scoring on the anterior neck of femoral component and this corresponded to some impingement on the anterior cup. Doi: (b)(6) 2008, dor: (b)(6) 2015, left hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07473 |
| MDR Report Key | 9818706 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-20 |
| Date of Event | 2015-11-17 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-11 |
| 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 | KXA |
| Date Received | 2020-03-11 |
| 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 | 2020-03-11 |