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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); Migration or Expulsion of Device (1395); Loss of Osseointegration (2408); Migration (4003)
Patient Problems Pain (1994); No Code Available (3191)
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, 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

"literature article entitled, ¿impaction bone-grafting of severely defective femora in revision total hip surgery: 21 hips followed for 41-85 months¿ by frans c. Van biezen, et al, published by acta orthopaedica scandinavia (2000), vol. 71, no. 2, pp. 135-142, was reviewed. The purpose of this article was to review the efficacy of femoral impaction bone grafting in thas for patients with severe bone defects implanted between september 1992-september 1995. The authors used competitor and depuy tha components. This complaint captures the individual results for patients implanted with cemented depuy charnley products. The cement utilized is unknown. The manufacturer of the components used in revision are unknown. Patient 4: (b)(6) female. Charnley stem revised due to periprosthetic fracture, stem loosening of an unknown interface, and stem migration. Patient 7: (b)(6) female. Revised charnley stem due to pain, stem loosening of an unknown interface, and stem migration secondary to non-union of the femoral osteotomy site (bone injury). Patient 8: (b)(6) female. Revised charnley stem due to pain and stem loosening of an unknown interface. Patient 12: (b)(6) female. Revised charnley stem due to pain and stem migration secondary to loosening of the stem. Patient 20: (b)(6) male patient. Revised charnley stem due to pain, stem loosening of an unknown interface, and 4-mm stem migration. Patient 21: (b)(6) female. Revised charnley stem due to pain, periprosthetic femoral fracture, stem loosening of an unknown interface, and 3-mm stem migration. Patient 16: (b)(6) female. Patient experienced a dislocation of a charnley cup and a competitor femoral head. Treatment for the dislocation is unknown. ".

 
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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 Key9654712
MDR Text Key186456025
Report Number1818910-2020-03720
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeNL
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 01/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/31/2020
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 Received02/05/2020
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: 01/31/2020 Patient Sequence Number: 1
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