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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 9; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Catalog Number SPT-090000S
Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Date 05/22/2020
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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.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 injury is considered to be under the scope of this recall.No further investigation is required.
 
Event Description
As reported: "removal and replacement of rejuvenate recalled modular stem, pre-op diagnosis - failed right total hip arthroplasty." spoke to rep, who provided additional patient and product information.All devices except the shell were revised to a stryker poly liner and competitor femoral devices.Rep has some additional pictures to provide, and confirmed that no further information will be released by the hospital or surgeon.
 
Event Description
As reported: "removal and replacement of rejuvenate recalled modular stem, pre-op diagnosis - failed right total hip arthroplasty." spoke to rep, who provided additional patient and product information.All devices except the shell were revised to a stryker poly liner and competitor femoral devices.Rep has some additional pictures to provide, and confirmed that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
Reported event: an event regarding revision due to implant failure 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 no 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 due to implant failure is considered to be under the scope of this recall.No further investigation is required.H3 other text : device not returned.
 
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Brand Name
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9
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 Key10147661
MDR Text Key194927308
Report Number0002249697-2020-01159
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 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2015
Device Catalogue NumberSPT-090000S
Device Lot NumberMHTN98
Was Device Available for Evaluation? No
Date Manufacturer Received07/28/2020
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 Age71 YR
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