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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII MODULAR SHORT NECK PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

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STRYKER ORTHOPAEDICS-MAHWAH ABGII MODULAR SHORT NECK PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Catalog Number 4845-4-410
Device Problem Insufficient Information (3190)
Patient Problems Inflammation (1932); Reaction (2414)
Event Date 06/23/2020
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices. The reported elevated levels of cobalt and chromium is considered to be under the scope of this recall. No further investigation is required.
 
Event Description
After the procedure with abgii modular, metallosis diagnosed in (b)(6) 2014 and therefore the need for further revision, explant and replacement of the prosthesis.
 
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Brand NameABGII MODULAR SHORT NECK
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
NA
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood, NJ WD6 3-SJ
GB   WD6 3SJ
2018315000
MDR Report Key10269575
MDR Text Key198696035
Report Number0002249697-2020-01420
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K092406
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2015
Device Catalogue Number4845-4-410
Device Lot NumberG3005812
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 Received08/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2010
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: 07/14/2020 Patient Sequence Number: 1
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