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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, CALC

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STRYKER ORTHOPAEDICS-MAHWAH ABGII. MODULAR STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Catalog Number 4845-4-104
Device Problem Insufficient Information (3190)
Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)
Event Date 02/19/2018
Event Type  Injury  
Manufacturer Narrative
An event regarding revision due to pain and loosening involving an abgii modular stem was reported. The event was not confirmed. Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned. Clinician review: no medical records or x-rays were made available for evaluation. Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced. Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided. If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
 
Event Description
Information received from legal: plaintiff alleges the right rejuvenate implanted on (b)(6) 2012. Failed causing pain and elevated metal ion levels. Plaintiff has not yet scheduled right revision surgery. Suit filed in mn. Update 16-jul-18: it was reported that patient's right hip was revised due to elevated cobalt and chromium levels. Rep reported that intra-operatively, there was no appearance of tissue damage. The head was well-fixed to the degree that in attempting to remove the head, the entire head/ neck/ stem construct came out of the patient (rep reported the stem was loose), and no trunnion wear was observable as a result. The stem, neck, head and liner were revised to a secur-fit plus max stem with a ceramic head and poly liner. The shell was well-fixed, well-positioned, and was not revised.
 
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Brand NameABGII. MODULAR STEM
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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7779597
MDR Text Key116995700
Report Number0002249697-2018-02516
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 consumer,other
Reporter Occupation
Type of Report Initial
Report Date 08/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2016
Device Catalogue Number4845-4-104
Device Lot NumberG3040116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/13/2018 Patient Sequence Number: 1
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