MAUDE Adverse Event Report: ZIMMER GMBH ZIMMER FITMORE STEM AND COCR HEAD; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED OR NON-POROUS,UNC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Fatigue (1849); Failure of Implant (1924); Memory Loss/Impairment (1958); Neuropathy (1983); Pain (1994); Blood Loss (2597); Test Result (2695)

Event Date 09/01/2014

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2014, he received a right total hip arthroplasty via the anterior approach with zimmer fitmore stem with a 36mm cocr head, continuum shell and longevity liner.Previously, on (b)(6) 2014, he received a left tha with the same implant, noted on the op note as zimmer fitmore size 4 stem, 36mm +10 metal (aka cocr) head, 56 acetabular and a lip liner places at 9 o'clock.His right hip pain began in (b)(6) of 2014 after doing physical therapy to a rehabilitate the hip.He recalls that the pain onset suddenly and was notable when carrying a heavy cooler.Pain x-ray of the hips made on (b)(6) 2019 showed that the right femoral stem was not osseointegrated and had settled 1.3 cm suggestive of fibrous fixation.On (b)(6) 2016, his serum / plasma cobalt level was 1.5 mcg/l.In addition, he has noted new onset of fatigue, peripheral neuropathy, disordered mood and some new memory issues.On (b)(6) 2016, the right tha was revised due to fibrous fixation aseptic loosening of the right femoral stem and elevated cobalt levels.The right hip was revised to a wagner sl revision stem 16mm by 265mm, revision polyethylene longevity highly crosslinked polyethylene 7 mm insert for retained continuum shell, size of insert kk, new head was biolox ceramic head size 36mm +7, 12/14 taper.There was moderate capsular thickness.There was fluid in the joint that was under some degree of pressure.The fitmore stem was loose and subsided and extracted without difficulty.Complications of this revision procedure included perforation of posteriolateral femoral cortex during attempt to reestablish femoral canal because of bony pedestal requiring extensile femoral exposure and excessive blood loss of 3 liters related to injury to perforating vessels at the time of posterolateral femoral perforation.In (b)(6) 2019, following revision of the right hip, his blood cobalt level was now 0.6 mcg/l and his urine cobalt level was 0.8 mcg/l.He still has a cocr head on the left hip.Fda safety report id# (b)(4).

• Brand Name: ZIMMER FITMORE STEM AND COCR HEAD
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED OR NON-POROUS,UNC
• Manufacturer (Section D): ZIMMER GMBH ; warsaw IN
• MDR Report Key: 9728395
• MDR Text Key: 180179592
• Report Number: MW5093051
• 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: 02/14/2020
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 113