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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 48 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 48 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999800748
Device Problems Use of Device Problem (1670); Loss of Osseointegration (2408); Malposition of Device (2616); Naturally Worn (2988); Osseointegration Problem (3003)
Patient Problems Wound Dehiscence (1154); Cyst(s) (1800); Edema (1820); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Distress (2329); Impaired Healing (2378); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Event Date 11/01/2019
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. Occupation is a non-healthcare professional. (b)(4).
 
Event Description
Medical records received. After review of medical records, the patient was revised to address aseptic loosening, acetabular protusio, pseudotumor secondary to metal on metal reaction, rupture of adductor tendon mechanism and fascial dehiscence. Prior to being revised, patient reports pain. Workup elsewhere reveals a loose cup with acetabular protusio and rotation of the cup into a passive vertical position. Intraoperatively, a cystic mass was opened and there was milky, non-purulent fluid consistent with metal on metal disease. The abductors were repaired. It was confirmed that the acetabular component was loose and had rotated 90 degrees into the base of the acetabulum. Metal on metal metallic debris was found in the posterior acetabular wall as well as on the trunnion. Doi: (b)(6) 2009; dor: (b)(6) 2019 (right hip).
 
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Brand NameASR ACETABULAR CUPS 48
Type of DeviceASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopedics drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9490250
MDR Text Key174906744
Report Number1818910-2019-123803
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2014
Device Catalogue Number999800748
Device Lot Number2821637
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2009
Is the Device Single Use? Yes
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: 12/18/2019 Patient Sequence Number: 1
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