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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 Problems Degraded (1153); Insufficient Information (3190)
Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 06/29/2020
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 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
It was reported that the patient's right hip was revised due to the presence of a rejuvenate modular stem construct. Intra-operatively, metallosis was noted at the head/ neck interface. The stem construct, lfit v40 head, and liner were revised. Rep confirmed there are no allegations against the revised poly liner. Rep confirmed that he has pictures relating to the event, and 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 Key10288216
MDR Text Key199226756
Report Number0002249697-2020-01468
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 health professional,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2016
Device Catalogue NumberNLS-380000B
Device Lot Number36764201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/08/2011
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: 07/17/2020 Patient Sequence Number: 1
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