MAUDE Adverse Event Report: ZIMMER BIOMET BIOLOX DELTA CERAMIC HEADS ; METAL/CERAMIC, POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED

Device Problem Corroded (1131)

Patient Problems Purulent Discharge (1812); Memory Loss/Impairment (1958); Pain (1994); Synovitis (2094); Blurred Vision (2137); Toxicity (2333); Numbness (2415)

Event Date 04/14/2009

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2009, he received a right total hip arthroplasty.Implants used were a 56od by 50mm id biomet m2a pf cup for a magnum taper lock metal on metal configuration with a 10mm by 140mm long taperlock noncemented femoral prosthesis with a 42/50 standard taper adaptor, and a 50mm magnum cocr head was used.In (b)(6) of 2009, he developed parkinsonism and was started on medications.By 2010, these symptoms worsened, and in (b)(6) 2012, he had a right subthalamic dbs implantation, which was hardly managing his symptoms at one of the highest settings.On (b)(6) 2010, he received a left total hip arthroplasty with the same biomet m2a magnum metal on metal hip device.Components for the left tha are listed as m2a biomet magnum pf cup 56od/50id press fit and noncemented.The stem was 12.5 by 145mm standard taper-lock nor cemented with a 42/50 mm taper adaptor, -3mm neck and a 50mm head with a 42/50 adaptor.In (b)(6) of 2012, he had a serum / plasma cobalt level of 116 mg/l and in (b)(6) of 2012 a serum / plasma cobalt level of 108 mg/l.In (b)(6) 2012, the pt reported moderate pain the right hip and severe pain in the left hip and groin pain extending to the posterior aspect of the left high and iliotibial band.In addition to accelerated parkinsonism, he experienced blurry vision, memory loss, tongue numbness, and dysgeusia.On (b)(6) 2012, the left tha was revised due to severe elevation of blood cobalt levels, metallosis and pain at the joint.The revision implant was a biomet regenerex ringloc cup 58mm outer diameter, e polyethylene ringloc acetabular liner, 40mm liner with the +3 high wall, 6.5 cancellous bone screws x2, central hole cover x1 biolox taper +3 neck length and a 40mm biolox delta ceramic head.There was some metal debris located in the soft tissues the rims of the short external rotators and capsule.There was a moderate amount of clear yellow serous fluid in the capsule with some metal staining to the tissues about the hip and there was evidence of synovitis due to the metal debris.On (b)(6) 2012, the right tha was revised due to pain, high cobalt levels, and significant metallosis.The magnum metal on metal was revised to a 58mm od regenerex acetabular shell, 6.5mm cancellous bone screws x2, central hole cover x1, 40mm diameter e polyethylene highly cross-linked acetabular insert with a high wall, 40mm biolox delta ceramic femoral head with minus 3 sleeve.There was a moderate amount of murky yellow fluid present within the joint with some metal staining.Formal analysis of the explanted materials revealed a total volumetric surface wear loss of a total of 104.5mm cubed from the left hip and 3 mm cubed from the right hip.His serum /plasma cobalt level was 3.2 mcg/l at about 5 weeks after revision of the right hip and on 0.7 mcg/l at about 7 weeks post-revision.In (b)(6) of 2019, he drastically reduced his parkinson's medication, and his condition was much improved.He is pursuing removal of the deep brain stimulator, which is set to the lowest possible setting.Fda safety report id# (b)(4).

• Brand Name: BIOLOX DELTA CERAMIC HEADS
• Type of Device: METAL/CERAMIC, POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 9733504
• MDR Text Key: 180717940
• Report Number: MW5093124
• Device Sequence Number: 10
• 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: 02/14/2020
• 11 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 90