MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_MDM LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number UNK_SHC

Device Problem Corroded (1131)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 11/10/2016

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 2 on (b)(6) 2016.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.".

• Brand Name: UNKNOWN_MDM LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10072520
• MDR Text Key: 191535277
• Report Number: 0002249697-2020-00945
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention