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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Event Date 01/03/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Reporter occupation: lawyer. (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
Asr litigation and medical records received. Litigation alleges pain, lack of mobility, metallosis, severe mom reaction, loss left hip abductor muscles, weakness, restricted range of motion, discomfort, excessive metal ions level and emotional distress. It was also alleged that a temporary antibiotic acetabular spacer was implanted. After review of medical records, clinical visits reported trochanteric burstis and discomfort. Doi: (b)(6) 2007; dor: (b)(6) 2018; left hip.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided. Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. 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 FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
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
6107428552
MDR Report Key8713545
MDR Text Key148464590
Report Number1818910-2019-96308
Device Sequence Number1
Product Code KWY
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,Followup,Followup,Followup
Report Date 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
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 Received05/07/2020
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: 06/19/2019 Patient Sequence Number: 1
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