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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 4845-4-205
Device Problem Device-Device Incompatibility (2919)
Patient Problems Unspecified Infection (1930); Metal Related Pathology (4530)
Event Date 12/15/2021
Event Type  Injury  
Manufacturer Narrative
Reported event: an event regarding infection and corrosion involving a abgii modular device was reported. The event was confirmed. Method & results: device evaluation and results: device evaluation was not performed as no devices were received. Device history review: review of device history records found the devices in the reported lot were accepted into final stock with no reported discrepancies. Complaint history review: the complaint databases show there have not been other events for the reported lot or sterile lot. Similar events have occurred for the catalog number and product family. These events(infection, corrosion) were determined to be associated with ra 2012-067. Conclusions all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10-6 in accordance to applicable iso standards. 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 infection and corrosion are considered to be under the scope of this recall. No further investigation is required. Device not returned to the manufacturer.
 
Event Description
It was reported a stage 1 revision was performed on the patient's right hip due to infection. Intra-operatively, surgeon reported that the cup 'spun out' and that there was corrosion at the stem/ neck junction of the modular stem. All components were removed and a spacer was placed.
 
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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
arokiya raj
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13205507
MDR Text Key288699916
Report Number0002249697-2022-00048
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092406
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number4845-4-205
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/10/2022 Patient Sequence Number: 1
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