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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problems Off-Label Use (1494); Malposition of Device (2616)
Patient Problems Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)
Event Date 05/14/2019
Event Type  Injury  
Manufacturer Narrative

Product complaint : (b)(4). Or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

It was reported that the stryker constrained with broken liner,summit stem, pinnacle cup had the poly cemented in 22. 225 + 4 head on summit in a bipolar head old metal on metal. Removed cup 28+5 head with metal on metal. Doi: unknown. Dor: may 14, 2019. Left hip.

 
Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameUNKNOWN HIP ACETABULAR CUP
Type of DeviceHIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8662963
MDR Text Key146806938
Report Number1818910-2019-95058
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 05/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP ACETABULAR CUP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2019
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: 06/03/2019 Patient Sequence Number: 1
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