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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 Problem Malposition of Device
Event Date 05/07/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

The primary surgery was performed on (b)(6) 2020 via tha. After the primary surgery, the hospital found that the trial liner (p/n: 221832048) was lost. The trial liner was not found even the hospital searched it. On end of (b)(6) 2020, the dislocation which was caused by cup¿s anterior opening angle was confirmed. On (b)(6) 2020, the revision surgery was performed by replacing the cup (p/n: unknown), the head (p/n: unknown) and the trial liner (p/n: 221832048) due to the dislocation. During the surgery, when removing the liner, the surgeon found that the implanted liner was the trial liner. At the primary surgery, the surgeon had not noticed that the implanted liner was the trial liner. The revision surgery was completed with no surgical delay. No further information is available.

 
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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 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 Key10087812
Report Number1818910-2020-12523
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup,Followup
Report Date 05/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP ACETABULAR CUP
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2020
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: 05/26/2020 Patient Sequence Number: 1
Treatment
UNKNOWN HIP ACETABULAR CUP
UNKNOWN HIP FEMORAL HEAD
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