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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL METAL ACETABULAR LINER

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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL METAL ACETABULAR LINER Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER METAL
Device Problem Noise, Audible (3273)
Patient Problems Wound Dehiscence (1154); Ossification (1428); Fatigue (1849); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/15/2019
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
Unf and medical records received. After review of medical records patient was revised to addressed painful metal on metal left hip arthroplasty. Prior to revision patient alleged weakness, click in her hip that be heard and felt, elevated cobalt level. Sharp dissection down to fascia layer was performed, upon exposure to the trochanter there was obvious prior repair and subsequent dehiscence of the anterior gluteus medius. Noticeable large protrusion of heterotopic ossification was removed. Acetabular screws were noted, one(1) of which appeared to be slightly prominent in the cup, this was removed. Doi: (b)(6) 2007, dor: (b)(6) 2019 left hip.
 
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Brand NameUNK HIP ACETABULAR LINER METAL
Type of DeviceMETAL ACETABULAR LINER
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 dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11731484
MDR Text Key247487768
Report Number1818910-2021-08839
Device Sequence Number1
Product Code KWA
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 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER METAL
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 Received05/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/27/2021 Patient Sequence Number: 1
Treatment
36 MM METAL HEAD; 36 MM METAL LINER; 6.5 MM SCREW; S3 CEMENTLESS SUMMIT POROUS COATED STEM
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