UNKNOWN HIP FEMORAL STEM UNK HIP FEMORAL STEM

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 2020-03-05 for UNKNOWN HIP FEMORAL STEM UNK HIP FEMORAL STEM manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[188899731] Product complaint # (b)(4). Occupation: lawyer. (b)(4). 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


[188899732] Pcf and medical records received. After review of medical records, patient was revised to address adverse local tissue reaction with metallosis after right total hip arthroplasty with significant lysis and greater trochanteric fracture along with pseudotumor. Operative notes stated that radiographs showed osteolysis and lucency under acetabular shell as well as elevated esr and crp. An aspiration of the hip revealed white blood cell count greater than 6000 as well as a left shift. A ct scan showed possibility of pseudotumor and elevated cobalt and chromium levels. Incision was made laterally, dissected down to the iliotibial band to gluteus medius vastus lateralis and found obvious greater trochanteric fracture that was comminuted as well as loss of the calcar when the stem was examined. There was a tremendous amount of metal stained tissue. The bone also appeared stained with metal debris. When the head was removed, the trunnion was exposed with significant amount of metal oasis. Attention was in acetabular component, significant amount of anteversion was noted. There was a large area of pseudotumor and was excised. There was also a fluid on the hip. There was a significant erosion of the acetabulum with loss of mainly the anterior wall. No indication of infection. There was significant amount of posterior impingement noted and the trunnion of the femoral stem had been impinge posteriorly on the cup for many years. Doi: (b)(6) 2008 - dor: (b)(6) 2018; right hip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-06917
MDR Report Key9792957
Report SourceCONSUMER,OTHER
Date Received2020-03-05
Date of Report2020-02-18
Date of Event2018-10-17
Date Mfgr Received2020-03-23
Date Added to Maude2020-03-05
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 FEMORAL STEM
Generic NameHIP FEMORAL STEM
Product CodeKXA
Date Received2020-03-05
Catalog NumberUNK HIP FEMORAL STEM
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2020-03-05

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