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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 8DEG 34MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 8DEG 34MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number NLV-340800G
Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 01/01/2014
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 two 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 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices. The reported pain is considered to be under the scope of this recall. No further investigation is required.
 
Event Description
Per medical records in pi, rejuvenate stem and neck was revised to restoration modular stem and body due to metal on metal reaction. Update: - (b)(6) 2013 rejuvenate modular hip was revised to restoration modular due to increasing pain and increased metal ions.
 
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 two 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 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices. The reported pain is considered to be under the scope of this recall. No further investigation is required.
 
Event Description
Per medical records in pi, rejuvenate stem and neck was revised to restoration modular stem and body due to metal on metal reaction. Update: - (b)(6) 2013 rejuvenate modular hip was revised to restoration modular due to increasing pain and increased metal ions.
 
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Brand NameLRG TAP PRI MOD NCK 8DEG 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
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key13169363
MDR Text Key286044469
Report Number0002249697-2022-00021
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 Other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2016
Device Catalogue NumberNLV-340800G
Device Lot Number37865501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2011
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: 01/05/2022 Patient Sequence Number: 1
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