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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP
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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problem Use of Device Problem (1670)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 07/11/2020
Event Type  malfunction  
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.
 
Event Description
The literature article entitled, "the direct anterior approach total hip arthroplasty reliably achieves ¿safe zones¿ for combined anteversion" written by j.Benjamin jackson iii, md, j.Ryan martin, md, aric christal, md, john l.Masonis, md, bryan d.Springer, md, and j.Bohannon mason, md published by arthroplasty today accepted by publisher on 11 july 2020 was reviewed.The article's purpose was to analyze the combined femoral and acetabular anteversion with cross-sectional imaging and quantify relative to the cv "safe zone" described by dorr.Data was compiled from 30 enrolled patients who all received a corail femoral stem and pinnacle cup.The article reports all measurements were in the safe zone with the exception of 20 cups in too much anteversion.No reported patient harms.Depuy product: pinnacle cup.Adverse event: mispositioned cups (no treatment provided).
 
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.
 
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Brand Name
UNKNOWN HIP ACETABULAR CUP
Type of Device
HIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10879455
MDR Text Key218511596
Report Number1818910-2020-25175
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Type of Report Initial,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR CUP
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/13/2020
Initial Date FDA Received11/20/2020
Supplement Dates Manufacturer Received12/10/2020
Supplement Dates FDA Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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