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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP IMPLANT

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP IMPLANT Back to Search Results
Catalog Number UNK HIP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Tissue Damage (2104); Weakness (2145); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 09/19/2015
Event Type  Injury  
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. Initial reporter occupation: non-healthcare professional ¿ attorney. (b)(4).
 
Event Description
Litigation alleges patient was revised to address pain, weakness, slipping and loosening sensations, inhibited ability to move, and metallosis. Ppf alleges metal wear and bone fracture. Doi: (b)(6) 2005; dor: (b)(6) 2015; (left hip).
 
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Brand NameUNKNOWN HIP IMPLANT
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6107428552
MDR Report Key8202373
MDR Text Key131591297
Report Number1818910-2018-79334
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP
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 Received09/20/2019
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: 12/28/2018 Patient Sequence Number: 1
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