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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 0DEG 38MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

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STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 0DEG 38MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Catalog Number NLS-380000B
Device Problem Device-Device Incompatibility (2919)
Patient Problems Inflammation (1932); Pain (1994); Local Reaction (2035)
Event Date 01/18/2013
Event Type  Injury  
Manufacturer Narrative
This event was previously reported under rae 2013-004. This report will document additional information received. Reported event: an event regarding altr involving a rejuvenate 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 been other events for the reported lot. Similar events have occurred for the catalog number and product family. These events were determined to be associated with ra 2012-067. 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 altr is considered to be under the scope of this recall. No further investigation is required.
 
Event Description
It is reported that: patient is asymptomatic. Information received from legal on (b)(6) 2015: plaintiff alleges the left rejuvenate hip implanted on (b)(6) 2010 failed causing pain and elevated metal ion levels. Plaintiff has not yet scheduled revision surgery. Suit filed in (b)(6). Update (b)(6) 2020 (b)(4): spoke to rep via phone. It was reported that the patient's left hip was revised on (b)(6)/2020 due to altr. All components were revised. Rep provided the primary usage report and confirmed there were no allegations against the revised head and liner. The shell was revised both to change its position and allow for an mdm metal liner and adm/ mdm poly insert to be implanted. Rep confirmed that no further information will be released by the hospital or surgeon.
 
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Brand NameLRG TAP PRI MOD NCK 0DEG 38MM
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
EI NA
Manufacturer Contact
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key10688272
MDR Text Key211856244
Report Number0002249697-2020-02144
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092561
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2013
Device Catalogue NumberNLS-380000B
Device Lot Number26582101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2090-2012

Patient Treatment Data
Date Received: 10/16/2020 Patient Sequence Number: 1
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