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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2 ASR HIP SYSTEM : HIP FEMORAL SLEEVE

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DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2 ASR HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 999800312
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Loss of Range of Motion (2032); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/14/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Asr xl revision received. Pfs has no allegation reported. After review of medical records patient was revised was due to metallosis, pain, loss of functional ability and increasing metal ion levels however no laboratory results reported. Operative notes upon opening the bursa there was gray fluid found. Femoral ball was brought into the wound and there was a very small notch a couple millimeters deep and the trunnion where the band impinging on the very sharp edge of the asr socket. Doi: (b)(6) 2009, dor: (b)(6) 2017 , right hip.
 
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Brand NameADAPTER SLEEVES 12/14 +2
Type of DeviceASR HIP SYSTEM : HIP FEMORAL SLEEVE
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
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13076102
MDR Text Key282704010
Report Number1818910-2021-28724
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,Consumer
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 12/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2013
Device Catalogue Number999800312
Device Lot Number2762420
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2008
Is the Device Single Use? No
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: 12/23/2021 Patient Sequence Number: 1
Treatment
ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT POR TAPER SZ5 HI OFF
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