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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 56 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 56 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999800756
Device Problems Device Dislodged or Dislocated (2923); Migration (4003)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Swelling/ Edema (4577)
Event Date 05/21/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Plaintiff preliminary disclosure and medical record received. After review of medical record, patient was revised to address dislocated acetabular component. Patient alleges pain and has degenerative disease of the lumbar spine. X-rays was obtained and noted that there is a complete dislodgement/dislocation of the acetabular cup with approximately 180 degrees of rotation of the cup within the native bony acetabulum. The posterior pseudocapsule were elevated from the posterior aspect. There was significant amount of serosanguineous fluid that did not appear purulent. There was minimal evidence of any bony ingrowth on the porous surface of the cup. There was osteolysis at the posterior femur which was curetted of fibrous debris. The trunnion showed minimal evidence of corrosion. Doi: (b)(6) 2008, dor: (b)(6) 2020, (right hip).
 
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Brand NameASR ACETABULAR CUPS 56
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 8 DT
UK LS11 8 DT
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14572961
MDR Text Key293145187
Report Number1818910-2022-09923
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
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2013
Device Catalogue Number999800756
Device Lot Number2703694
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2008
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: 06/02/2022 Patient Sequence Number: 1
Treatment
ADAPTER SLEEVES 12/14 +8.; ASR UNI FEMORAL IMPL SIZE 49.; SUMMIT DUOFIX TAP SZ8 HI OFF.
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