STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_REJUVENATE STEM SIZE 7; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_JR |
Device Problems
Device-Device Incompatibility (2919); Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414)
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Event Date 01/01/2014 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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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Manufacturer Narrative
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Reported event: an event regarding infection and abnormal ion level 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 could not be performed as the reported device was not properly identified.Complaint history review: a search of the complaint databases could not be performed as the reported device was not properly identified.Similar events have occurred for the rejuvenate modular product family.These events were determined to be associated with (b)(4).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 infection and abnormal ion level is considered to be under the scope of this recall.No further investigation is required.
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Event Description
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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 (b)(6) 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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Search Alerts/Recalls
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