MAUDE Adverse Event Report: ZIMMER, INC FEMORAL STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6305-50-32

Device Problems Degraded (1153); Material Discolored (1170)

Patient Problems Fatigue (1849); Hearing Impairment (1881); Failure of Implant (1924); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Blurred Vision (2137); Sore Throat (2396); Numbness (2415); Tooth Fracture (2428); Balance Problems (4401); Unspecified Mental, Emotional or Behavioural Problem (4430); Metal Related Pathology (4530); Localized Skin Lesion (4542); Swelling/ Edema (4577)

Event Date 11/23/2020

Event Type  Injury  

Event Description

Revision surgery for failed left total hip arthroplasty with trunnionosis and resultant metallosis.Following a metal total hip replacement on (b)(6) 2015.I experienced a gradual onset of neurological symptoms, with left hip, buttock and lower back pain, radiating down the extremity.I subsequently developed a mylar (butterfly) rash, burning throat and ears, blurry vision, hearing and memory impairment, tooth breakdown, mouth sores with residual pain, numbness in lips, hands, swollen fingers with impaired grasp, loss of balance, fatigue and dysphoria.A blood test for metal ions was conducted through the (b)(6) clinic in (b)(6) 2020.Results confirmed toxic levels of cobalt and chromium, and elevated levels of titanium.An emergency revision surgery was recommended.Due to covid precautions the revision was delayed until (b)(6) 2021.Operative findings indicated "clear evidence of trunnionosis with blackening of the trunnion".Subsequent pathology reports describe "prosthetic wear debris reaction including granulomatous response to metal particles".Versys hip system surgery included: femoral head 12/14 taper, 32mm diameter and 10mm neck length, lot# 62847098, edi (b)(4), ref 8018-32-02, femoral stem, lot# 62833317, edi (b)(4), ref 00-7864-013-00, 12/14 neck taper standard neck offset, size 13, 138mm stem length cementless.Trilogy acetabular system liner lot# 62842925, edi (b)(4), ref 6305-50-32, bone screw lot 62825599 and shell with cluster holes porous lot# 62779497.I was informed the removed implants were sent to (b)(6).Fda safety report id# (b)(4).

• Brand Name: FEMORAL STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ZIMMER, INC
• MDR Report Key: 15806908
• MDR Text Key: 303917381
• Report Number: MW5113312
• Device Sequence Number: 3
• 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: Patient
• Type of Report: Initial
• Report Date: 11/14/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6305-50-32
• Device Lot Number: 62825599, 62779497, 62842925
• Patient Sequence Number: 1
• Treatment: BABY ASPIRIN ; DICLOFENAC; GABAPENTIN; PROBIOTIC ; SAMBUCOL ; TYLENOL; VITAMIN D3
• Patient Outcome(s): Disability; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White