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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 Ossification (1428); Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)
Event Date 10/26/2013
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> no device was received. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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, "long-term results and bone remodeling after tha with a short, metaphyseal-fitting anatomic cementless stem" written by young-hoo kim, md, jang-won park, md, jun-shik kim, md, and jun-seok kang, md published by clinical orthopaedics and related research published online 26 october 2013 was reviewed. The article's purpose was to review long term results of in total hip arthroplasties in utilizing depuy cementless immediate postoperative stability stem (ips). Data was compiled from 500 patients (630 hips) age range 20-63 years. The article provides figure 2a-b for radiographic imaging noting a 40 year old male with "acetabular and femoral components are well fixed in a satisfactory position in both hips without osteolysis. Grade 2 calcar resorption is evident in both hips, but periprosthetic bone stock is well preserved without having stress shielding-related bone osteopenia. " depuy products utilized: ips stem, duraloc cup, ceramic on ceramic bearing adverse events: reports of clicking sound (no information regarding interventions) leg length discrepancy of less than 2 mm (no interventions required) calcar stress shielding by radiographic detection (no interventions required) heterotopic ossification by radiographic detection (no impact on function and no interventions required) infection (treated by revision of femoral and acetabular components) dislocation (treated by revision of acetabular components).
 
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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
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key9632783
MDR Text Key185343525
Report Number1818910-2020-03033
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,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
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 Received02/27/2020
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: 01/27/2020 Patient Sequence Number: 1
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