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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 Problems Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)
Event Date 03/21/2017
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

"literature article entitled, ¿experience of the posterior lip augmentation device in a regional hip arthroplasty unit as a treatment for recurrent dislocation¿ by l. Hoggett, et al, published by journal of orthopaedics (2017), vol. 14, pp. 512-514, was reviewed. The purpose of this article is to review the authors¿ experience using the posterior lip augmentation device (plad) to treat recurrent dislocations implanted between january 2007 and november 2012 in 55 hips. Implanted depuy products: all patients had a charnley polyethylene cup paired with a charnley monoblock stem. The plad devices were secured with 5 screws. Dislocation occurred in all hips prior to implantation of the plad device. Results after plad insertion: there were 14 patients who required reoperations or revisions. 8 reoperations for dislocations. Treatment included closed reduction, plad revision, acetabular revision, and/or conversion to a girdlestone. 1 plad revision due to screw breakage. 1 tha revision due to aseptic loosening of the stem. 3 cases of infection treated with irrigation and debridement and/or tha revision surgery. Radiographic results: there were 26 cases of radiographically identified trochanteric fracture at the osteotomy site prior to plad insertion. Treatment was not specified. The authors do not specify if any of these events were associated with the revision surgeries noted in the article. There were 35 cases of radiographically identified polyethylene wear noted before plad insertion. 11 cases were confirmed macroscopically during plad insertion surgery. Impacted products: charnley polyethylene cup: implant dislocation, implant bearing wear. Charnley monoblock stem: implant loosening/interface unknown, implant dislocation, fracture. Plad implant: no reported product problem. Plad screw: implant fracture/metal. Health impact: surgical intervention, device revision, and medical device removal. Symptoms: infection, joint dislocation".

 
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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 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9716378
MDR Text Key188708249
Report Number1818910-2020-04983
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeUK
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 02/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP FEMORAL STEM
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 Received03/02/2020
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: 02/17/2020 Patient Sequence Number: 1
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