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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 Use of Device Problem (1670); Loss of Osseointegration (2408); Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)
Event Date 02/10/2008
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, "dislocation of an s-rom total hip arthroplasty secondary to traumatic femoral stem dissociation from the metaphyseal sleeve" written by david w. Fabi, md, wayne m. Goldstein, md, and alexander c. Gordon, md published by the journal of arthroplasty vol. 24 no. 1 2009 accepted by publisher 10 february 2008. The article's purpose was to report on a case of a femoral stem and metaphyseal sleeve dissociation. The case was a (b)(6) female with left tha implanted with srom modular hip system. Medical comorbidities include hypertension, rheumatoid arthritis, hypothyroidism, and diabetes mellitus. She experienced a fall with negative radiographic findings for fracture or dislocation. She continued to experience left groin pain and left lateral proximal femur and continued negative findings in radiographic images so was diagnosed with muscle strain. Then she experienced a dislocation and was treated with closed reduction, abduction brace and physical therapy. She then experienced another dislocation and it was decided for revision to be performed. The plan was to replace the acetabular component and femoral head component with larger sizes but intraoperative findings revealed the stem to be retroverted and slightly loose. The sleeve was well fixed. Stem was removed and inner portion of sleeve was irrigated cleaned. Surgeon planned to implant a longer stem but one was not available during operation so surgeon placed a distal medullary canal plug, miig was injected in a retrograde fashion and new stem of the same dimension was reinserted. The patient did not experience any further complications and recovered well.

 
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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 Key9395796
MDR Text Key185083334
Report Number1818910-2019-118670
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2019
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 Received12/12/2019
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: 12/02/2019 Patient Sequence Number: 1
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