UNKNOWN HIP ACETABULAR LINERS UNK HIP ACETABULAR LINER

MAUDE Adverse Event Report

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 ACETABULAR LINERS UNK HIP ACETABULAR LINER manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[188869167] (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


[188869168] 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 east lansing 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 xanthochrornic 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


MAUDE Entry Details

Report Number1818910-2020-09405
MDR Report Key9885103
Report SourceCONSUMER,OTHER
Date Received2020-03-26
Date of Report2020-03-10
Date of Event2018-02-07
Date Mfgr Received2020-03-10
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN HIP ACETABULAR LINERS
Generic NameHIP ACETABULAR LINERS
Product CodeKWY
Date Received2020-03-26
Catalog NumberUNK HIP ACETABULAR LINER
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-26

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