MAUDE Adverse Event Report: ZIMMER BIOMET BIOMET M2M-MAGNUM METAL ON METAL HIP IMPLANT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER POROUS UNCEMENTED

Catalog Number US157858

Device Problem Corroded (1131)

Patient Problems Apnea (1720); Fatigue (1849); Hearing Loss (1882); Inflammation (1932); Memory Loss/Impairment (1958); Pain (1994); Blurred Vision (2137); Toxicity (2333); Shaking/Tremors (2515); No Code Available (3191)

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2008, he received a left total hip arthroplasty with uncemented biomet component 13.5mm lateralized taperloc femoral stem, 58 mm qd m2m-magnum pf cup (ref no: (b)(4), lot no 331910), 52mm od m2m-magnum modular head (ref no (b)(4), lot no 608420) with a standard taper adaptor.In (b)(6) 2018, metal suppression mri of the left hip showed left hip joint effusion.In 2018 he suddenly developed tremor in the right pinky finger, balance issues, memory loss, increased irritability, poor pain tolerance, obstructive sleep apnea, fatigue, peripheral neuropathy of both hands, hearing loss, and blurred vision.In addition to this, he has also been experiencing new problems with eczema.On (b)(6) 2018, he had a pacemaker implantation for sinus node dysfunction.On (b)(6) 2019, he was evaluated for significant left hip pain.On (b)(6) 2019, urine cobalt level was 4.1 mcg/l.On (b)(6) 2019, his whole blood cobalt level was 0.5 mcg/l.On (b)(6) 2019, serum plasma cobalt level was 0.8 mcg/l and urine cobalt was 6.9 mcg/l.Neuro q analysis of his fdg pet brain scan was notable for abnormal hypometabolism compatible with very early signs of chronic toxic encephalopathy.On (b)(6) 2019, he had the left tha revised for elevated cobalt levels, adverse reaction to metallic debris at the left hip, possible cobalt cardiomyopathy, and possible cobalt encephalopathy.New implant consisted of a zimmer / biomet continuum socket multiple hole 60mm od, 36mm id constrained longevity liner, 36mm biolox option delta ceramic head, taper adaptor +3 neck.The old stem was sound and in about 15 degrees of anteversion.The trunnion and head bore showed moderate corrosive debris.There was no lysis.Posterior capsule was deficient and anterior capsule was thickened due to adverse reaction to metallic debris, abduction tendons were inflamed and attenuated requiring repair, and the trochanteric bursa was inflamed.Frozen section of left hip tissue had alval score of 5 out of 10.Cobalt level of right hip joint fluid was 0.8 mcg/l.On (b)(6) 2020, his whole blood cobalt level was 0.5 mcg/l and urine cobalt was 0.7 mcg/l.Fda safety report id# (b)(4).

• Brand Name: BIOMET M2M-MAGNUM METAL ON METAL HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER POROUS UNCEMENTED
• Manufacturer (Section D): ZIMMER BIOMET ; warsaw IN
• MDR Report Key: 9793259
• MDR Text Key: 182543578
• Report Number: MW5093537
• Device Sequence Number: 1
• Product Code: LPH
• 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: 03/02/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: US157858
• Device Lot Number: 331910
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 122