MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-31 for ARTICULEZE M HEAD 36MM -2 1365-50-000 136550000 manufactured by Depuy Orthopaedics Inc Us.
[186728916]
(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
[186728917]
After review of medical records patient was revised to address pain and metallosis. Revision notes reported of a chronic-appearing rupture of the anterior aspect of the gluteus medius. There was obvious evidence of metallosis staining. Clinic visits reported of trochanteric bursitis and elevated metal ions. Doi: (b)(6) 2009. Dor: (b)(6) 2019, (left hip). The patient has bilateral hip implants, please see (b)(4) for the right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09738 |
| MDR Report Key | 9903861 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-07-10 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2008-07-25 |
| Date Added to Maude | 2020-03-31 |
| 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 INT'L LTD. 8010379 |
| Manufacturer Street | ST ANTHONYS ROAD |
| 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 | ARTICULEZE M HEAD 36MM -2 |
| Generic Name | ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS |
| Product Code | JDI |
| Date Received | 2020-03-31 |
| Model Number | 1365-50-000 |
| Catalog Number | 136550000 |
| Lot Number | 2706336 |
| Device Expiration Date | 2013-07-31 |
| 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 | 2020-03-31 |