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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 Problem Naturally Worn (2988)
Patient Problems Test Result (2695); No Code Available (3191)
Event Date 05/17/2018
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. (b)(4).
 
Event Description
The literature article entitled, "prevalence of subclinical cardiac abnormalities in patients with metal - on- metal hip replacements" written by f. Lodge, r. Khatun, r. Lord, a. John, a. G. Fraser, and z. Youse published by international journal of cardiology made available online 17 may 2018 was reviewed. The article's purpose: "we therefore performed a cross-sectional study of orthopaedic patients who had received mom hip prostheses to: a) ascertain the prevalence of overt cardiomyopathy and b) evaluate any relationship between subclinical markers of cardiac dysfunction and levels of plasma cobalt and chromium. " data set was compiled from 95 mom hip patients and 15 controls with non mom hip prostheses. It is noted that depuy products are listed with non-depuy products utilized for mom prostheses. Article reports 18 patients had undergone prosthesis removal with average of 611 days post implantation. Article reports increased plasma cobalt level was associated with increasing heart size but "subjects had no evidence of myocardial dysfunctions in regards to the cardiac aspect of the study. It is noted that patients had elevated cobalt (co) and chromium (cr) levels. The article associates elevated ion levels to the metal on metal bearing surfaces articulation releasing metal related particles. The article does not provide clarification on which specific products are associated with specific adverse events. Depuy products: corail stem, pinnacle cup, metal liner, metal head. Adverse events: removal of prosthesis. Elevated ion levels.
 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr
warsaw, IN 46581-0988
6107428552
MDR Report Key10303599
MDR Text Key208203459
Report Number1818910-2020-16444
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER
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 Received07/27/2020
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: 07/21/2020 Patient Sequence Number: 1
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