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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_REJUVENATE STEM SIZE 7 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_REJUVENATE STEM SIZE 7 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number UNK_JR
Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 01/01/2014
Event Type  Injury  
Manufacturer Narrative

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.

 
Event Description

This pi is for revision 1 on 2014. It was reported through a medwatch report (mw5093597) "pt id (b)(6): on (b)(6) 2014, his left stryker rejuvenate hip was revised for infection. New implant was stryker titanium hemispherical revision acetabular shell size 58, with a mdm liner and the appropriate mom polyethylene component, size 16x190 zimmer wagner sl. Revision stem with a 28mm +3. 5 biolox ceramic head and 2 cerclage wires. Explant was stryker rejuvenate stem size 7 with a straight 34mm 127 degree neck and a 28mm +0 biolox ceramic head, size 56 adm cup with cocr component. On (b)(6) 2013, prior to revision of the rejuvenate implant, his serum/plasma cobalt level was 15 mcg/l. On (b)(6) 2014, following revision of the rejuvenate, plasma cobalt level was 2. 8 mcg/l. Echocardiogram done on (b)(6) 2015, showed grade ii diastolic dysfunction. He reported symptoms of sleep and mood disorder, which were complicated by his diagnosis of ptsd from military service. Neuro q analysis of fdg pet brain scan showed significant generalized and focal hypometabolism compatible with chronic toxic encephalopathy. On (b)(6) 2015, his urine cobalt level was 10. 5 mcg/l. On (b)(6) 2015, urine cobalt level was 2. 2 mcg/l and serum /plasma cobalt level was 1. 5 mcg/l. On (b)(6) 2016, urine cobalt level was 9. 9 mcg/l. On 05/17/2016, serum/plasma cobalt level was 1. 4 mcg/l. Metal suppression mri of the left hip showed increased fluid about the joint as well as posterior capsule thickening with pseudotumor. On (b)(6) 2016, the left hip was revised again elevated cobalt levels, adverse reaction to metal debris, the stryker mom cocr socket liner with mom bearing and zimmer biolox head were explanted. The new implant was a stryker x3 socket liner lipped 36mm id and biolox delta option ceramic head 36mm +0. The old stem was sound and in about 30 degrees of anteversion. The trunnion and head bore showed ti transfer to the bore of ceramic head. There was about 20cc pressurized clear yellow joint effusion. At removal of the liner that was notable black corrosion debris on the back side of the cocr liner and the inner interface of the acetabular shell. Pathology reports of frozen section of left hip synovium notable for exhibiting focal chronic inflammatory change. Formal explant analysis notable for "severe corrosion" at the nonarticular surface of the cocr acetabular liner. ".

 
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Brand NameUNKNOWN_REJUVENATE STEM SIZE 7
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key10072522
MDR Text Key191534751
Report Number0002249697-2020-00943
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2020
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2020
Was Device Evaluated By Manufacturer? No
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: 05/19/2020 Patient Sequence Number: 1
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