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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)
Patient Problems Fatigue (1849); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Numbness (2415); Joint Laxity (4526)
Event Date 06/01/2017
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Article entitled "effect of total hip arthroplasty for congenital dysplasia of hip in adults" written by tao zhenggang, wu fangfang, mo wenhai, and zhu xiaobing published by chines journal of clinical health care on june 1, 2017 was reviewed.In this study, 61 patients (71 hips) who underwent tha with subtrochanteric osteotomy were analyzed of ddh patient data to observe their follow-up effect.71 hips were implanted with a competitor acetabular prosthesis and srom femoral prosthesis.Adverse events: 3 hips sustained a femoral fracture during the operation and were treated with steel wire fixation.1 hip had a sciatic nerve injury, foot numbness, and weakness and was treated with conservative treatment.1 hip had post op pain, decreased rom, soft tissue laxity, and luxation.Treated with manual reduction.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
UNKNOWN HIP FEMORAL HEAD
Type of Device
HIP FEMORAL HEAD
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
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14743681
MDR Text Key294488257
Report Number1818910-2022-11282
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL HEAD
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/08/2022
Initial Date FDA Received06/20/2022
Supplement Dates Manufacturer Received06/29/2022
Supplement Dates FDA Received06/29/2022
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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