• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET ZIMMER BIOMET UNIVERSAL NAVIGATION ORTHOPEDIC STEREOTAXIC INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET ZIMMER BIOMET UNIVERSAL NAVIGATION ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 15742
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZIMMER BIOMET UNIVERSAL NAVIGATION
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET
warsaw IN
MDR Report Key9793259
MDR Text Key182543578
Report NumberMW5093537
Device Sequence Number2
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received03/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number15742
Device Lot Number608420
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/04/2020 Patient Sequence Number: 1
-
-