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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 4845-4-206
Device Problem Degraded (1153)
Patient Problems Hyperplasia (1906); Inflammation (1932); Pain (1994); Injury (2348); Depression (2361); Reaction (2414)
Event Date 09/24/2012
Event Type  Injury  
Manufacturer Narrative
An event regarding revision due to pain and altr involving an abgii modular device was reported. The event was confirmed. Conclusions: 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 revision due to pain and altr is considered to be under the scope of this recall. No further investigation is required.
 
Event Description
In (b)(6) 2012 the patient started to feel pain also the left hip, and the x-ray showed peritrochanteric calcifications. On (b)(6) 2013 he underwent a revision surgery on the right hip and on (b)(6) 2013 on the left hip. The patient reportedly has synovial hyperplasia, metallosis, depression, unanticipated surgical procedure.
 
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. The following device was also listed in this report: unknown mitch acetabular cup 58 insert 52-4. The mitch trh acetabular system components are oem devices manufactured by depuy. Stryker orthopaedics is not the legal manufacturer of the mitch devices and does not have reporting responsibilities. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time due to the ongoing litigation. Should additional information become available, the evaluation summary will be submitted in a supplemental report. A voluntary recall (b)(6) was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices. Not available.
 
Event Description
In (b)(6) 2012 the patient started to feel pain also the left hip, and the x-ray showed peritrochanteric calcifications. On (b)(6) 2013 he underwent a revision surgery on the right hip and on (b)(6) 2013 on the left hip. The patient reportedly has synovial hyperplasia, metallosis, depression, unanticipated surgical procedure.
 
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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
MDR Report Key7215246
MDR Text Key291635275
Report Number0002249697-2018-00220
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K092406
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/25/2014
Device Catalogue Number4845-4-206
Device Lot NumberG2778153
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2089-2012

Patient Treatment Data
Date Received: 01/24/2018 Patient Sequence Number: 1
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