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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII. MODULAR STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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STRYKER ORTHOPAEDICS-MAHWAH ABGII. MODULAR STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number 4845-4-104
Device Problem Device-Device Incompatibility (2919)
Patient Problems Pain (1994); Metal Related Pathology (4530); Insufficient Information (4580)
Event Date 05/10/2010
Event Type  Injury  
Manufacturer Narrative
Voluntary recall ra (b)(4) was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.
 
Event Description
This report is for the unknown right femoral stem abg ii howmedica n°4 ha. As part of the abg ii modular hip prosthesis recall, the patient will undergo a revision surgery on (b)(6) 2022.
 
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Brand NameABGII. MODULAR STEM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
EI NA
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key13169232
MDR Text Key283295266
Report Number0002249697-2022-00019
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K092561
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number4845-4-104
Device Lot NumberG2944486
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2089-2012

Patient Treatment Data
Date Received: 01/05/2022 Patient Sequence Number: 1
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