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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 Pain (1994); Sepsis (2067); Injury (2348); Osteolysis (2377); No Code Available (3191)
Event Date 04/18/2001
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, ""cementless total hip arthroplasty in young chinese patients" written by k. Y. Chiu, fhkam (ortho surg), w. M. Tang, fhkam (ortho surg), t. P. Ng, fhkam (ortho surg), k. C. Poon, frcs (ed), w. Y. Ho, frcs (ed), and k. M. Lee, afrcse (ed) published by the journal of arthroplasty vol. 16 no. 7 2001 doi:10. 1054/arth. 2001. 25505 on 18 april 2001 was reviewed for mdr reportability. The article reports that 27 patients out of 51 received depuy aml implants with the remainder being non depuy. The 27 patients with aml implants had 9 aml acetabular components implanted before 1991 and the remainder 18 had duraloc acetabular components thereafter. The femoral heads were 28 mm in diameter for the aml hips. No further information given regarding materials. Clinical outcomes for the 51 patients include mild pain that did not limit activities (4); revisions (10) for the following reasons: aseptic loosening unspecified anatomical location (1), poly wear with osteolysis (7), late sepsis (2). The article further states: "the acetabular component alone was revised in 2 hips; the acetabular component and the femoral component were revised in 3 hips; the polyethylene liner and the hip ball were exchanged without changing the metal acetabular component or the femoral component in 5 hips. The reoperation rate did not differ significantly between (non depuy product) and aml hips (p 5. 53)" the article does not specify which products are related to the clinical outcomes or adverse events. The article notes on radiographic findings: heterotopic ossification was noted in a total of 25 hips out of 51 hips total, 43 hips demonstrated some degree of stress shielding, osteolytic lesions were found around 4 aml acetabular components and 8 femoral components. The article consistently reports no differences of rates or percentages for adverse events between aml and the non-depuy counterpart which indicates that at least one or more of the aforementioned adverse events can be associated with at least one or more depuy aml or duraloc products but exact quantities are unknown.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> no device was received. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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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
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key9154299
MDR Text Key167648138
Report Number1818910-2019-107373
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
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 Received12/03/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/03/2019 Patient Sequence Number: 1
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