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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problems Loss of Osseointegration (2408); Malposition of Device (2616)
Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 04/13/2019
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, "revision of failed metal-on-metal total hip arthroplasty: midterm outcomes of 203 consecutive cases" written by david a. Crawford, md, joanne b. Adams, bfa, cmi, michael j. Morris, md, keith r. Berend, md, and adolph v. Lombardi jr. , md, facs published by the journal of arthroplasty published online 13 april 2019 was reviewed. The article's purpose was to report on midterm outcomes of 203 revisions for failed metal-on-metal total hip arthroplasties. The article provides table 1 with a list of depuy and non-depuy products that were revised (203 total). It is noted that depuy had 13 asr and 10 ultamet cases out of the 203 total revisions. Cement manufacturer was not identified. Table 2 provides original revision reasons but does not specify which revision reason are associated with depuy products. Therefore, accurate quantities cannot be determined based upon information provided by article. The article also reports that 28 cases with patient identifiers (table 4) required re-revision and the reasons but does not provide the details of what implants were utilized during revision or re-revision. Cross reference and narrative descriptions also do not provide adequate information to capture the identified patients. This pc will only capture the original identified depuy products that were revised for unspecified listed reasons. If further information is provided, this pc will be updated and the appropriate reports will be filed. Figure 1 provides radiographic images of a revised mom without product or patient identification that required a re-revision. Depuy products: asr head, asr cup, asr augment, unknown stem, metal head, ultamet liner, pinnacle cup. Revision reasons: adverse reaction to metal debris. Acetabular aseptic loosening. Infection. Femoral aseptic loosening. Dislocation. Fracture (article indicates fractures were periprosthetic femoral). Cup malposition.

 
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Brand NameUNKNOWN HIP ACETABULAR CUP
Type of DeviceHIP ACETABULAR CUP
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 drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10071697
MDR Text Key191531095
Report Number1818910-2020-12270
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
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 Received05/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP ACETABULAR CUP
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/19/2020 Patient Sequence Number: 1
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