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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Nonstandard Device (1420); Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Fever (1858); Unspecified Infection (1930); Necrosis (1971); Pain (1994); No Code Available (3191)
Event Date 01/01/2006
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
An article ¿acute delayed infection: increased risk in failed metal on metal total hip arthroplasty¿ by hernan a. Et al on retrospective reporting of a series of 124 patients (20 females and 104 males, average age of 51. 5 years) with asr implants presenting with acute delayed or late periprosthetic joint infection (pji) as a mode of failure for this particular design between june 2006 and february 2010. Total 143 consecutive metal-on-metal primary thas (124 patients), performed with the depuy asr xl acetabular hip system (112 hips) and depuy asr hip resurfacing system (31 hips). 8 male cases were reported with confirmed periprosthetic deep infection, 6 cases with asr xl acetabular system and 2 cases with asr hip resurfacing system. Of those 8 deep pji, 4 cases presented as a delayed acute infection (>3 < 24 months after the index primary hip arthroplasty), and 4 cases presented with a late infection after 24 months. Loosening of cup along with metallosis was reported in one case. Two hips required irrigation and debridement with component retention (1 hip resurfacing arthroplasty and 1 total hip arthroplasty before the recall had occurred), two hips underwent irrigation and debridement with acetabular revision and retention of well-fixed femoral component (after recall occurred) and 4 hips were treated with 2-stage exchange. All the patients are identifiable for reported adverse event. Cup loosening, cup malposition, infection, metallosis, irrigation and debridement, acetabular revision were observed due to depuy asr xl acetabular hip system and depuy asr hip resurfacing system. Case #4 (b)(6) year-old male with asr implantation received revision 5 months post initial implantation. The article clarifies he received only irrigation and debridement during revision and retained all device components(per table 1 page 1810). It is noted that implantation measurements of the cup 50 degrees abduction angle and 30 degrees ante-version angle. Noted are the following patient adverse events: surgery intervention, pain, fever, chills, drainage, redness, infection, necrosis, no explantation of components. Noted are the following product adverse events: malpositioned cup.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara depuy synthes
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8833481
MDR Text Key152496197
Report Number1818910-2019-99416
Device Sequence Number1
Product Code KWY
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received08/28/2019
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
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 07/26/2019 Patient Sequence Number: 1
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