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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); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Patient Problems Ossification (1428); Bone Fracture(s) (1870); Unspecified Infection (1930); Injury (2348); Joint Dislocation (2374); No Code Available (3191)
Event Date 10/30/2007
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, "the results of a proximally-coated cementless femoral component in total hip replacement" written by y. H. Kim published by the journal of bone and joint surgery accepted after revision 30 october 2007. The article's purpose was to review the results of a cementless anatomical femoral component to give immediate post-operative stability, and with a narrow distal section in order not to contact the femoral cortex in the diaphysis, ensuring exclusively metaphyseal loading. Data was compiled from 601 hips in 471 patients age ranging 20 to 63 years and consisted of 297 men and 174 women receiving implants between march 1995 and february 2002. All implants were depuy products. The article includes radiographic images. Depuy products: cementless ips stem, duraloc cups (with screw at times), ceramic liner, ceramic femoral head adverse events: clicking sound (no interventions provided) grade 2 and grade 3 stress shielding at calcar (radiographically detected and no interventions) distal pedestals (radiographically detected and no interventions) infection (treated by revision of both acetabular and femoral components) recurrent dislocation (treated by revision of acetabular components) intraoperative calcar fracture (treated with cabling) avulsion fracture of greater trochanter (no interventions provided) grade 2 heterotopic ossification (no functional impact and no interventions provided) figure 2a and 2b provide radiographic imaging of a 38 year old man with grade iii calcar atrophy (no interventions provided).
 
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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
6103142063
MDR Report Key9637938
MDR Text Key185351010
Report Number1818910-2020-03257
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 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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: 01/28/2020 Patient Sequence Number: 1
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