MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. WRIGHT MEDICAL TECHNOLOGY CONSERVE PLUS HIP RESURFACING; PROSTHESIS, GENERAL RESURFACTING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Tinnitus (2103); Numbness (2415); Test Result (2695)

Event Date 09/14/2018

Event Type  Injury  

Event Description

Pt id: (b)(6), on (b)(6) 2001, he received a left total hip arthroplasty for severe osteoarthritis of the left hip.Implant was a conserve plus resurfacing size 60/50.The resurfacing improved him and he does not endorse any problems at the hip.Though, he was developing significant pain at the right hip due to osteoarthritis of the right hip.Since the resurfacing, he has noticed ringing in ears and hearing loss and numbness in all fingers of the left hand.He also developed a fine rest tremor of the right hand.On (b)(6) 2018, his urine cobalt level was 3.2 mcg/l, cobalt blood level was 0.6 mcg/l, and chromium serum level was 1.0 mcg/l.Metal suppression mri of the left hip showed no sings of adverse reaction to metallic debris about the left hip.Fdg pet brain scan with neuro q analysis showed focal and generalized mild hypometabolism potentially suggestive of early chronic toxic encephalopathy.His elevated cobalt levels, early brain changes, and neurological symptoms are concerning and should be investigated further.Fda safety report id# (b)(4).

• Brand Name: WRIGHT MEDICAL TECHNOLOGY CONSERVE PLUS HIP RESURFACING
• Type of Device: PROSTHESIS, GENERAL RESURFACTING
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC. ; memphis TN 38117
• MDR Report Key: 9621634
• MDR Text Key: 176285888
• Report Number: MW5092399
• Device Sequence Number: 1
• Product Code: NXT
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 113