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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 Problems Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Necrosis (1971); Test Result (2695); No Code Available (3191)
Event Date 08/21/2016
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, ¿601 metal-on-metal total hip replacements with 36 mm heads a 5 minimum year follow up: levels of armd remain low despite a comprehensive screening program¿ by amit atrey, et al, published by journal of orthopaedics (2017), vol. 14, pp. 108-114, was reviewed. The purpose of this article is a retrospective study to assess the clinical outcome, failure rate, and reason for failure of a large consecutive series of 36 mm mom corail/pinnacle total hip replacements (thrs). Implanted depuy products: pinnacle cup, metal liner, cocr femoral head, and corail stem. Results: 100 patients had elevated blood metal ions greater than 7 ppb. The mean cobalt level was 120 ppb and chromium level was 135 ppb. These patients were given additional screening with ultrasound and aspirate of the periarticular joint fluid. 12 of these patients were revised and captured in case 1-case 2. There were incidences of elevated blood metal ions in the revisions for dislocation, infection, and loosening. 6 head and liner revisions due to dislocation. 4 revisions due to infection. The components revised were unspecified. 1 patient requested revision due to elevated blood metal ions. 2 stem and head revisions due to limb asymmetry. 4 revisions due to aseptic loosening of either the cup or head. Captured in pc-000600950: pinnacle cup: implant loosening. Acetabular liner: implant dislocation. Femoral head: implant dislocation. Corail stem: implant loosening. Patient harms: surgical intervention, medical device removal, elevated blood metal ions, joint dislocation, inadequate osseointegration, limb asymmetry, infection. This article provides detailed information for 12 patients who were revised due to armd as evidences by elevated blood metal ions, histological confirmation of armd using hip aspirate, or ultrasound evidence of pseudotumor/pseudocapsule. These patients are captured in the attached guidance document labeled case 1-case 12. The parent pc-000600950 captures the revisions and results not identified by patient. " (b)(6) female implanted with a pinnacle cup, metal liner, cocr femoral head, and corail stem. Revised cup, head, and liner due to armd. Preoperative symptom: clicking of the operative hip. Blood metal ions: co 131 ppb cr 46 ppb. Intraoperative findings: soft tissue necrosis, and periarticular synovial thickening consistent with foreign body reaction. There was no reported product problem with the stem or the cup.
 
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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 Key9454191
MDR Text Key184932851
Report Number1818910-2019-122586
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCA
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 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
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 Received02/03/2020
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/11/2019 Patient Sequence Number: 1
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