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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER CERAMIC CERAMIC ACETABULAR LINER Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER CERAM
Device Problems Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Joint Laxity (4526)
Event Date 03/15/2021
Event Type  Injury  
Manufacturer Narrative

Product complaint #: (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 patient has history of rheumatoid arthritis and avascular necrosis. Patient had bilateral hip replacements in 2006 at the mayo clinic. Right hip implants included a summit porous-coated stem, a 52 mm duroloc ceramic option cup with a ceramic liner, and a 32mm +1 mm ceramic hip head. Patient has had ongoing right hip pain, with increased squeaking in the (b)(6) of 2020. She noted a grinding sensation and instability in her right hip, with increased discomfort while leaning forward. The surrounding hip muscles were increasingly sore, with some pain while walking every day. The replacement surgery noted the presence of a black stain on the ceramic head and on the tip of the ceramic liner. The surgeon suggested the staining was caused by the trunion of the stem rubbing on the rim of the liner. The liner was intact until it was fractured during the removal. The stem remained well fixed and was left in place. The cup and liner of a competitive company was implanted, with depuy 36mm, 1. 5 mm ceramic ts head used. Doi: 2006 dor: (b)(6) 2021 right hip.

 
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Brand NameUNK HIP ACETABULAR LINER CERAMIC
Type of DeviceCERAMIC ACETABULAR LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key11595348
MDR Text Key243334822
Report Number1818910-2021-06630
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP ACETABULAR LINER CERAM
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/31/2021 Patient Sequence Number: 1
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