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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); Thrombosis/Thrombus (4440); Physical Asymmetry (4573)
Event Date 08/17/2020
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, ¿long-term outcomes of total hip arthroplasty with transverse subtrochanteric shortening osteotomy and modular stem in crowe iv developmental dysplasia. ¿, published by the journal of arthroplasty, was reviewed. The purpose of this study is to evaluate the rate of union, the revision rate, functional scores, and complications in patients with crowe iv ddh treated with total hip arthroplasty, transverse subtrochanteric shortening osteotomy, and modular stem in an average 10-year follow-up. Twenty-eight patients (33 hips) with crowe iv ddh who were operated on between 2008 and 2013 were followed. All patients underwent uncemented total hip arthroplasty with transverse subtrochanteric shortening osteotomy and anatomical acetabular cup implantation. The mean age was 36. 6 years, and the mean follow-up period was 121 months. Crowe iv ddh patients treated with transverse subtrochanteric shortening osteotomy, modular stem, and anatomic acetabular component insertion can have satisfactory and reliable 10-year clinical outcomes. Complication: 3 cases of postoperative dislocation, 2 cases of intraoperative fracture occurred during bone prep, one of the fractures had patient identifier of (b)(6) female 1 case of posterior tibial venous thrombosis. Leg asymmetry was noted prior to implanting and also present in patient's post surgery.
 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
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 dr
warsaw, IN 46581
6107428552
MDR Report Key11106890
MDR Text Key227868861
Report Number1818910-2021-28100
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER
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 Received05/07/2021
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 Unkown

Patient Treatment Data
Date Received: 01/04/2021 Patient Sequence Number: 1
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