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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); Fracture (1260)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348); No Code Available (3191)
Event Date 12/12/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The literature article entitled, "outcomes of cement in cement revision, in revision total hip arthroplasty" written by abhijeet kumar, martyn porter, nikhil shah, chakshu gaba, and paul siney published by clinical science published online 12 december 2019 was reviewed. The article's purpose is to evaluate the effectiveness of cement-in-cement revision of the femoral stem while performing a revision tha. Data was compiled from 75 patients between june 2014 and june 2017. Depuy products were identified as "most" original stems removed among "variety of femoral stems. " depuy products were also identified among non-depuy products utilized in revision tha. Cement manufacturer is not identified. The article only identifies and reports on the femoral stems. Therefore, this pc captures the original depuy stems with related revision reasons and the revision depuy stems with related adverse events. Figures 3-5 and 7 provide radiographic imaging but does not identify depicted products. The adverse events in caption descriptions are captured in the generalized adverse events appropriately. Original depuy stems: charnley modular stem, c-stem amt. Revision reasons for original depuy and/or non-depuy stems: stem loosening (interface unknown). Peri-prosthetic fracture (femoral). Loss of bone stock. Femoral component stem fracture. Unexplained pain. Revision depuy stems: charnley modular stem, c-stem amt. Adverse events for revision depuy and/or non-depuy stems: infection (treated by antibiotics and/or 2 stage revision). Stem perforation (treated by re-revision). Periprosthetic femoral fracture (treated conservatively and orif). Sciatic nerve palsy (full recovery in 15 months post op; treatment not reported). Intraoperative fracture (treated by cerclage wire). Dislocations (involved components not identified or reported; treated by re-revision). Femoral component stem fracture (treated by re-revision).
 
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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)
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 Key10130191
MDR Text Key194474007
Report Number1818910-2020-13351
Device Sequence Number1
Product Code KWY
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 05/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received06/15/2020
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: 06/08/2020 Patient Sequence Number: 1
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