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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_REJUVENATE MODULAR STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_REJUVENATE MODULAR STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number UNK_JR
Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)
Patient Problems Pain (1994); Metal Related Pathology (4530)
Event Date 02/13/2024
Event Type  Injury  
Manufacturer Narrative
Although no catalog number or lot code was provided, similar events have occurred for the product family.These events were determined to be associated with ra 2012-067.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 requiring revision 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 left hip was revised due to elevated ion levels and pain.A rejuvenate modular stem construct, ceramic head and poly liner were revised to a restoration modular stem construct, ceramic head, adm/ mdm poly insert, and mdm metal liner.Rep can provide pictures, otherwise confirmed that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
An event regarding abnormal ion level involving an unknown rejuvenate modular stem was reported.The event was not confirmed.Method & results: -product evaluation and results: visual analysis of images provided showed signs of damage consistent with corrosion around the male end of the modular neck.-clinician review: summary: as described above a 72-year-old female underwent a primary total hip arthroplasty using a rejuvenate modular implant with a ceramic head and polyethylene liner in 2010.Patient developed elevated metal ion levels and underwent revision surgery on (b)(6) 2024.While several laboratory values were supplied there was no documentation of elevated ion levels.Confirmation of event: i can preliminarily confirm that the patient had a primary total hip arthroplasty with a rejuvenate implant, ceramic head, and polyethylene acetabular liner since i was able to see photos of explanted prostheses.However i have no documentation of the primary surgery or the revision surgery with no office notes, operation notes or x-rays of the primary implant or the revision implant.There is also no documentation of elevated ion levels.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of elevated metal ion levels and corrosion at modular junctions are multifactorial including surgical technique, especially in the way the trunnions and the modular parts are prepared for insertion and the way of implantation technique, the patient activity level and bmi, as well as implant factors.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to elevated metal ion levels.The exact cause of the event could not be determined because insufficient information was provided.A review with a clinical consultant of provided medical records indicated: summary: as described above a 72-year-old female underwent a primary total hip arthroplasty using a rejuvenate modular implant with a ceramic head and polyethylene liner in 2010.Patient developed elevated metal ion levels and underwent revision surgery on (b)(6) 2024.While several laboratory values were supplied there was no documentation of elevated ion levels.Confirmation of event: i can preliminarily confirm that the patient had a primary total hip arthroplasty with a rejuvenate implant, ceramic head, and polyethylene acetabular liner since i was able to see photos of explanted prostheses.However i have no documentation of the primary surgery or the revision surgery with no office notes, operation notes or x-rays of the primary implant or the revision implant.There is also no documentation of elevated ion levels.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of elevated metal ion levels and corrosion at modular junctions are multifactorial including surgical technique, especially in the way the trunnions and the modular parts are prepared for insertion and the way of implantation technique, the patient activity level and bmi, as well as implant factors.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.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 abnormal ion level is considered to be under the scope of this recall.No further investigation is required.
 
Event Description
It was reported that the patient's left hip was revised due to elevated ion levels and pain.A rejuvenate modular stem construct, ceramic head and poly liner were revised to a restoration modular stem construct, ceramic head, adm/ mdm poly insert, and mdm metal liner.Rep can provide pictures, otherwise confirmed that no further information will be released by the hospital or surgeon.
 
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Brand Name
UNKNOWN_REJUVENATE MODULAR STEM
Type of Device
PROSTHESIS, 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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key18884446
MDR Text Key337410094
Report Number0002249697-2024-00380
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
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age72 YR
Patient SexFemale
Patient Weight76 KG
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