MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-26 for UNKNOWN HIP FEMORAL STEM UNK HIP FEMORAL STEM manufactured by Depuy Orthopaedics Inc Us.
[187741471]
(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
[187741472]
Pcf and medical records received. After review of medical records, patient was revised to address painful right total hip replacement with suspected metallosis. Patient alleges pain. It was suspected that because these were metal-on- metal articulations that she might have developed a fluid accumulation or pseudotumor around the hip. Serum studies showed increased cobalt and chromium levels in her blood and the mars mri scan confirmed the fluid accumulation in the hip. This was addressed by interventional radiology in the (b)(6) area where she lives and the interventional radiologist removed approximately 30 ml of turbid fluid, which was sterile, but did show evidence of metallosis. Operative notes indicated that before entering the joint, a large bore needle was inserted and approximately 25 ml of fluid was aspirated. This had the appearance of a metal debris mixed in with the joint fluid. The soft tissue posteriorly along the femur was then opened through the old scar of the short rotator repair. This had partially torn and there was some evidence of fluid leaking out from this area. The hip was then brought into maximum internal rotation and dislocated. There was no gross metallosis present, but there was xanthochromic staining of the soft tissues in the entire hip area and capsule. The femur was then subluxed anteriorly and the acetabular component was addressed. This was circumferentially exposed removing additional reactive soft tissue back to healthy-appearing pseudocapsule. Doi: (b)(6) 2008. Dor: (b)(6) 2018; (right hip).
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1818910-2020-09407 |
MDR Report Key | 9885134 |
Report Source | CONSUMER,OTHER |
Date Received | 2020-03-26 |
Date of Report | 2020-03-10 |
Date of Event | 2018-02-07 |
Date Mfgr Received | 2020-03-10 |
Date Added to Maude | 2020-03-26 |
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 STEM |
Generic Name | HIP FEMORAL STEM |
Product Code | KWY |
Date Received | 2020-03-26 |
Catalog Number | UNK HIP FEMORAL STEM |
Lot Number | NA |
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 | 2020-03-26 |