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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER POLY

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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER POLY Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER POLY
Device Problem Naturally Worn (2988)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 05/10/2020
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.

 
Event Description

Literature article entitled "fourth generation head fracture in ceramic-on-polyethylene bearing after hip revision surgery: a case report" written by roberto valentini, andrea vacchiano, andrea sandri, dario regis, carlo dall¿oca, bruno magnan published by acta biomed published online/accepted by publisher 10 may 2020 was reviewed. The article's purpose was to examine fourth generation ceramic bearings which were developed to reduce wear debris and improve fracture resistance. The case study examines a fourth generation head fracture in ceramic-on-polyethylene coupling with subsequent revision. Data was compiled from a case study involving one patient. Computer tomography scans can be found on page 3 of the case study. Implant images and x-ray images can be found on page 4 of the case study. Adverse events: the patient underwent a right hip revision due to pain, decreased range of motion, implant fracture of the ceramic femoral head, and poly wear of the acetabular liner. The acetabular cup and femoral stem were both well-fixed and retained.

 
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Brand NameUNK HIP ACETABULAR LINER POLY
Type of DeviceACETABULAR LINER
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 Key11049498
MDR Text Key223064790
Report Number1818910-2020-27383
Device Sequence Number1
Product Code KWA
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 12/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP ACETABULAR LINER POLY
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 Received12/10/2020
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

Patient TREATMENT DATA
Date Received: 12/21/2020 Patient Sequence Number: 1
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