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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problem Naturally Worn (2988)
Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
Event Date 02/07/2018
Event Type  Injury  
Manufacturer Narrative
(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.
 
Event Description
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).
 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9885103
MDR Text Key188869167
Report Number1818910-2020-09405
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/26/2020 Patient Sequence Number: 1
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