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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 34MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 0DEG 34MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number NLS-340000B
Device Problem Degraded (1153)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 11/16/2020
Event Type  Injury  
Manufacturer Narrative
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. 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. 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 is considered to be under the scope of this recall. No further investigation is required. Not returned.
 
Event Description
It was reported that the patient is experiencing pain when standing up from a sitting position, walking and when on legs for too long gets tired and stiff. Additional information received from sales rep on (b)(6) 2020: it was reported that the patient's hip was revised due to infection. A rejuvenate modular stem, stryker femoral head, and competitor liner and shell were removed and a spacer placed. Rep can provide an x-ray and confirmed that no further information will be released by the hospital or surgeon. This pi is for the revision of the patient's hip on (b)(6) 2020 [removal of primary implants (rejuvenate modular stem and neck) and revision1 implants].
 
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Brand NameLRG TAP PRI MOD NCK 0DEG 34MM
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
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11010355
MDR Text Key221492040
Report Number0002249697-2020-02675
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,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2016
Device Catalogue NumberNLS-340000B
Device Lot Number37470502
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2011
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: 12/15/2020 Patient Sequence Number: 1
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