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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER POLY PINNACLE
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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER POLY PINNACLE Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER POLY
Device Problem Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 10/20/2020
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
The patient was revised due to wear of the acetabular liner.Doi: unknown, dor: (b)(6) 2020, affected side: right hip.
 
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 LINER POLY PINNACLE
Type of Device
ACETABULAR LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10791778
MDR Text Key214763229
Report Number1818910-2020-23981
Device Sequence Number1
Product Code KWY
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 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR LINER POLY
Was Device Available for Evaluation? No
Date Manufacturer Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
32MM 12/14 TAPER METAL FEMORAL HEAD; 32MM 12/14 TAPER METAL FEMORAL HEAD
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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