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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL; METAL ACETABULAR LINER

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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL; METAL ACETABULAR LINER Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER METAL
Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Osteolysis (2377)
Event Date 12/14/2020
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 hip pain and upon x-ray determined lysis of acetabulum.The patient has ---, lot #s are unreadable.Nothing further to add.Doi: (b)(6) 2009; dor: (b)(6) 2020; right hip.
 
Event Description
Additional information was received stating that the lot number were unreadable due to discoloration and was not able to personally look at them due to legal response from hospital.
 
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.H10 additional narrative: added: b5 corrected: h6 (device code).
 
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Brand Name
UNK HIP ACETABULAR LINER METAL
Type of Device
METAL ACETABULAR LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11088973
MDR Text Key224409628
Report Number1818910-2020-27781
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 12/14/2020
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? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR LINER METAL
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/14/2020
Initial Date FDA Received12/29/2020
Supplement Dates Manufacturer Received01/05/2021
Supplement Dates FDA Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK HIP FEMORAL HEAD CERAMIC.
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient Weight106
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