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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Wound Dehiscence (1154); Thrombosis (2100); Joint Dislocation (2374); No Code Available (3191)
Event Date 01/17/2018
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. (b)(4).
 
Event Description
The literature article entitled, "john charnley award: randomized clinical trial of direct anterior (daa) and miniposterior approach (mpa) tha: which provides better functional recovery?" written by michael j. Taunton, md, robert t. Trousdale, md, rafael j. Sierra, md, ken kaufman, phd, and mark w. Pagnano, md published by clinical orthopaedics and related research published online 17 january 2018. The article's purpose was to study and find answers to if daa result in faster return to activities of daily living than the mpa; if daa have superior patient-reported outcome measures than the mpa; if the daa result in improved radiographic outcomes than the mpa; and if daa have a higher risk of complications than the mpa. Data was compiled from 101 patients undergoing primary tha between march 1, 2013 and may 31, 2016. All components were uncemented and were depuy for the mpa group. The article does not identify the components for the daa group; therefore, only adverse events associated with mpa group are captured in this complaint. Depuy products utilized: corail stem, pinnacle cup, ceramic head and poly liner. Adverse events: 1) dislocation (treated with closed reductions) 2) wound dehiscence (treated with dressing changes and oral antibiotics) 3) intraoperative calcar fractures (treated with cables) 4) deep vein thrombosis (treated with xarelto).
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
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 Key9981677
MDR Text Key188390352
Report Number1818910-2020-11069
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 health professional,literatur
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received05/11/2020
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: 04/21/2020 Patient Sequence Number: 1
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