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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 Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)
Event Date 11/16/2015
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, "cementless revision total hip arthroplasty with ceramic articulation" written by jong-hyuck yang, md, seong-jo yang, md, joon-soon kang, md, kyoung-ho moon, md published by hip and pelvis 27(4): 223-231, 2015 with final publisher acceptance november 16, 2015 was reviewed. The article's purpose was to evaluate the clinical and radiological outcomes of revision tha using the third and fourth generation coc articulations in younger patients for intermediate-term durations. Data was compiled from 103 patients who received revision thas between january 2000 to aprils 2012 with mean age of 51. 6 years. Depuy products utilized (all patients): duraloc cups until june of 2007 and the pinnacle cups with ceramic liners. Ceramic femoral head with aml stems and solution stems. Original implants are not known or identified. Adverse events: squeaking noise (no interventions or revision), limp in walking and require walking aids, limb length discrepency (0 to 2 cm) without impact to function and no interventions, dislocation treated by closed reduction under general anesthesia and one treated with re-revision due to recurrent dislocations with change of cup (not identified) and head, joint infections treated with re-revision (pinnacle cup identified) with changing of cup and femoral head, cup re-revision due to loosening (pinnacle cup identified). The article does not provide adequate information to determine accurate quantities.
 
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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)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 46581-0988
6103142063
MDR Report Key9249518
MDR Text Key178252854
Report Number1818910-2019-112768
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
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 Received01/02/2020
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: 10/29/2019 Patient Sequence Number: 1
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