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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ULT*METAL CUP INNER 10DG32/50 HIP ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US ULT*METAL CUP INNER 10DG32/50 HIP ACETABULAR LINERS Back to Search Results
Catalog Number 852742
Device Problem Naturally Worn (2988)
Patient Problems No Code Available (3191); Insufficient Information (4580)
Event Date 05/07/2020
Event Type  malfunction  
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
Surgeon is ordering a patient specific hip inlay for a planned revision because of normal and expected pe-wear, left side. There has been no allegation of any product deficiency. Doi: (b)(6) 1995. Dor: (b)(6) 2020 (planned) left hip.
 
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Type of DeviceHIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9880199
MDR Text Key186731494
Report Number1818910-2020-09248
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number852742
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 Received01/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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