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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 7; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Catalog Number SPT-070000S
Device Problems Material Erosion (1214); Device-Device Incompatibility (2919)
Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 05/05/2020
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 wear 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.Intra-operatively, while removing the head the modular neck came out as well with no distraction required.Trunnion wear was noted.The rejuvenate modular stem and neck, 28 +0 lfit head, and adm/ mdm insert were revised.Rep confirmed there are no allegations against the revised insert.No further information will be released by the hospital or surgeon.Update 14/may/2020 : clarification to event description (trunnion wear) provided by rep: "the wear was between the neck and the stem.".
 
Manufacturer Narrative
Updated the event description and implant date to reflect the updates received june 11,2020.Reported event: an event regarding elevated metal ion levels and wear involving a rejuvenate modular device was reported.The event was confirmed for elevated ion levels.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: based on event details, wear between stem and neck is also reported.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 metal ion levels 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.Intra-operatively, while removing the head the modular neck came out as well with no distraction required.Trunnion wear was noted.The rejuvenate modular stem and neck, 28 +0 lfit head, and adm / mdm insert were revised.Rep confirmed there are no allegations against the revised insert.No further information will be released by the hospital or surgeon.Update 14/may/2020 : clarification to event description (trunnion wear) provided by rep: "the wear was between the neck and the stem." update the additional information received from legal on 06/11/2020: plaintiff was implanted with a right abg ii / rejuvenate modular hip stem on (b)(6) 2010.Its further alleged that the plaintiff had the right hip stem at issue explanted on (b)(6) 2020 due to elevated levels of cobalt and chromium in bloodwork.
 
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Brand Name
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7
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 Key10101520
MDR Text Key193295657
Report Number0002249697-2020-00989
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 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2015
Device Catalogue NumberSPT-070000S
Device Lot NumberMJHK12
Was Device Available for Evaluation? No
Date Manufacturer Received06/24/2020
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 Age63 YR
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