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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP ACETABULAR CUP ASR
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DEPUY INTERNATIONAL LTD - 8010379 UNK HIP ACETABULAR CUP ASR Back to Search Results
Catalog Number UNK ACETABULAR CUP ASR
Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 11/06/2020
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.
 
Event Description
It was reported that the patient was revised due to infection.All implants were well fixed.Nothing further to report.Doi: unknown; dor: (b)(6) 2020; unknown.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
 
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Brand Name
UNK HIP ACETABULAR CUP ASR
Type of Device
HIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key10869392
MDR Text Key217153752
Report Number1818910-2020-25027
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK ACETABULAR CUP ASR
Was Device Available for Evaluation? No
Date Manufacturer Received12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Treatment
54 ASR CUP; SROM SLEEVE 20; SROM STEM 20X15; UNK HIP ACETABULAR AUGMENT; UNK HIP FEMORAL HEAD METAL; 54 ASR CUP; SROM SLEEVE 20; SROM STEM 20X15; UNK HIP ACETABULAR AUGMENT; UNK HIP FEMORAL HEAD METAL
Patient Outcome(s) Required Intervention;
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