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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA MODULAR SLEEVE 12/14 M DELTAMOTION : HIP FEMORAL AUGMENT

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DEPUY ORTHOPAEDICS INC US DELTA MODULAR SLEEVE 12/14 M DELTAMOTION : HIP FEMORAL AUGMENT Back to Search Results
Catalog Number 167061F
Device Problem Noise, Audible (3273)
Patient Problem Joint Laxity (4526)
Event Date 11/12/2020
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

Delta motion cup and head exchange to treat noise and joint instability secondary to impingement. Surgeon implanted a competitor cup and ceramic ts head.

 
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Brand NameDELTA MODULAR SLEEVE 12/14 M
Type of DeviceDELTAMOTION : HIP FEMORAL AUGMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10934666
MDR Text Key219154730
Report Number1818910-2020-25939
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number167061F
Device LOT Number121591
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 Received03/26/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/05/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/02/2020 Patient Sequence Number: 1
Treatment
DELTA MODULAR HEAD 48MM; DELTA MODULAR SLEEVE 12/14 M
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