MAUDE Adverse Event Report: ZIMMER BIOMET ZIMMER BIOLOX HEAD; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERMIC POLYMER,CEMENTED OR NON-POROUS UNCE

Device Problem Corroded (1131)

Patient Problems Encephalopathy (1833); Unspecified Infection (1930); Swelling (2091); Toxicity (2333); Reaction (2414); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

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 a pseudotumor.On 11/10/2016, 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.Fda safety report id# (b)(4).

• Brand Name: ZIMMER BIOLOX HEAD
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERMIC POLYMER,CEMENTED OR NON-POROUS UNCE
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 9805062
• MDR Text Key: 183120043
• Report Number: MW5093597
• Device Sequence Number: 2
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention