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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problems Loss of or Failure to Bond (1068); Off-Label Use (1494)
Patient Problem No Code Available (3191)
Event Date 05/13/2020
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 doctor stated patient had a 44x62 poly cemented into a non depuy cup.28+5 large taper head in a 44 bipolar.Poly liner was loose in cement mantle.Doctor removed poly liner, head and bipolar and revised.Original implant date unknown.Doi: unknown.Dor: (b)(6) 2020.Affected side: right hip.
 
Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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Brand Name
UNKNOWN HIP ACETABULAR LINERS
Type of Device
HIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10093333
MDR Text Key192251089
Report Number1818910-2020-12659
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
Type of Report Initial,Followup
Report Date 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR LINER
Was Device Available for Evaluation? No
Date Manufacturer Received06/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
HIP ACETABULAR CUP (COMPETITOR); UNKNOWN HIP ACETABULAR POLY/METAL HEMI; UNKNOWN HIP FEMORAL HEAD
Patient Outcome(s) Required Intervention;
Patient Weight75
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