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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); Osseointegration Problem (3003)
Patient Problems Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)
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
"literature article entitled, ¿porous-coated cementless acetabular cups in revision surgery: a 6- to 1 1-year follow-up study¿ by eduardo garcia-cimbrelo, md, phd, published by the journal of arthroplasty (1999), vol. 14, no. 4, pp. 397-406, was reviewed. The purpose of this article was to review the efficacy of various types of acetabular bone grafting utilized during revision surgery performed between 1986 and 1991. The cups used in the index and revision surgeries were from various manufacturers. The authors utilized an unknown number of screws and unknown bone graft to secure the revision cups. The femoral components used are unknown. The authors used constrained liners assumed to be of the same manufacturer as the cup. There is insufficient information provided to determine the actual number of depuy products associated with the adverse events and radiographic findings noted within the article. Index tha components: 2 acs cups revised due to loosening of the bone to implant interface. Revision components: 14 duraloc cups paired with constrained liners and secured with an unknown number of acetabular screws. Re-revisions and interventions: an unknown number of cups and screws were revised due to cup loosening at the bone to implant interface. 3 duraloc cups were identified as ¿mechanical failures¿ due to pain. Treatment was unspecified. Progressive radiographic findings: unknown number of cups and screws were identified as migrated, loosened at the bone to implant interface. There were radiolucent lines found in one or more delee-charnley zones. 6 hips had radiographically identified broken screws. Fig. 6 on page 404 and fig. 4 on page 402 provides radiographic images of unknown loosened cups and broken screws. ".
 
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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)
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 Key9677615
MDR Text Key186374962
Report Number1818910-2020-04160
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 foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR CUP
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 Received02/24/2020
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: 02/06/2020 Patient Sequence Number: 1
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