MAUDE Adverse Event Report: ZIMMER BIOMET ZIMMER GENERIC COLLARED COCR STEM (SIMILAR TO PCA) AND COCR HEAD ; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS, UNCEMENTED

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Encephalopathy (1833); Fatigue (1849); Memory Loss/Impairment (1958); Necrosis (1971); Pain (1994); Tinnitus (2103); Toxicity (2333); Shaking/Tremors (2515); Test Result (2695)

Event Type  Injury  

Event Description

Pt id: (b)(6); her first hip arthroplasties were done around 1990 for avascular necrosis following a motor vehicle accident.She has had multiple subsequent revisions of the arthroplasties.Prior to final revision in 2016, the right hip had a zimmer generic collared cocr stem with proximal beading similar to pca, zimmer hg ii socket and 32mm id liner, 32mm cocr head with skirt and 3 dome screws.In 2014, she reports a 10-year history of progressive tinnitus and had echocardiographic abnormalities.Around (b)(6) 2015, she had onset of fatigue, memory problems, and tremor.She additionally began experiencing symptoms around the right tha.On (b)(6) 2014, serum chromium level was 5.3 mcg/l and serum cobalt was 3.2 mcg/l.On (b)(6) 2015, urine cobalt level was 23.6 mcg/l serum cobalt level was 2.5 mcg/l.Neuro q analysis of fdg pet brain study notable for global and focal hypometabolism suggestive of chronic toxic encephalopathy.On (b)(6) 2016, right total hip arthroplasty was revised for right hip pain, pseudotumor at right hip, and elevated blood cobalt level with neurological and cardiovascular symptoms concerning for possible cobalt toxicity.Her right hip was revised to a zimmer wagner sl 265x16mm delta ceramic 32mm +7 neck head, biomet g7 60mm socket with a +5 offset e1 polyethylene liner, 3 dome screws, and 3 luque wires 16-gauge and 100 c allopack with 1 gram vancomycin.The capsule appeared thickened and had a caseous interior surface consistent with either a reaction to metallosis or plastic debris.The trochanteric bursa and its pseudotumor extension were excised.Pathology report of frozen section of right hip synovium and pseudocapsule was notable for necrosis, fibrosis, and histiocytic infiltrate compatible with reaction to prosthesis with no evidence of infection.On (b)(6) 2016, urine cobalt level was 9.1 mcg/l and plasma cobalt level was 1.8 mcg/l.On (b)(6) 2016, urine cobalt level was 12.6 mcg/l and plasma cobalt level was 1.6 mcg/l.On (b)(6) 2016, plasma cobalt level was 1.9 mcg/l and on (b)(6) 2016, plasma cobalt level was 1.6 mcg/l.On (b)(6) 2016 and then again on (b)(6) 2016, she dislocated the right hip following the complex revision and her instability was related to insufficiency of her periprosthetic tissues due to damage from adverse reaction to metal debris.Fda safety report id# (b)(4).

• Brand Name: ZIMMER GENERIC COLLARED COCR STEM (SIMILAR TO PCA) AND COCR HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS, UNCEMENTED
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 9792924
• MDR Text Key: 182522306
• Report Number: MW5093522
• 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

1 Device was Involved in the Event

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
• 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