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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Catalog Number SPT-080000S
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 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.
 
Manufacturer Narrative
Reported event: an event regarding fretting 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 revision, metallosis is considered to be under the scope of this recall.No further investigation is required.H3 other text : device not returned.
 
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 Name
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key10288213
MDR Text Key199229546
Report Number0002249697-2020-01467
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K092561
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
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 Health Professional
Device Expiration Date09/30/2016
Device Catalogue NumberSPT-080000S
Device Lot NumberMKLMJH
Was Device Available for Evaluation? No
Date Manufacturer Received08/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2090-2012
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
Patient Weight118
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