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

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

Patient Problems Anemia (1706); Cardiomyopathy (1764); Emotional Changes (1831); Headache (1880); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Necrosis (1971); Pain (1994); Rash (2033); Tinnitus (2103); Blurred Vision (2137); Discomfort (2330); Toxicity (2333); Reaction (2414); Sweating (2444); Sleep Dysfunction (2517); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 03/09/2017

Event Type  Injury  

Event Description

On (b)(6) 2009, he underwent a right wright medical conserve plus resurfacing tha done by dr.(b)(6).The implant is a wright medical conserve plus resurfacing with 58 mm od and 52 mm id.He notes that he has always had some lateral right hip discomfort since surgery.In 2016, started developing significant peripheral neuropathy and new right hip groin pain, which became limiting.On (b)(6) 2017, his serum / plasma cobalt level was 1.3 ppb and his urine cobalt level was 17 ppb.He concurrently developed new problem with cognitive function including memory and confusion.He started experiencing new cardiomyopathy with new hypertension, new anemia, new diagnosis of sleep apnea, new night sweats, new tinnitus, new vision cloudiness, mood disorder, acute rash, headaches, and rest tremor.New angioedema and anaphylaxis to multiple medications.Metal suppression mri of the right hip showed adverse reaction to metallic debris involving a 2 cm intra-articular pseudotumor at the junction of the femoral resurfacing of the superior aspect of the femoral neck.On (b)(6) 2017, his right tha was revised to a zimmer ml t stem 11 ex, continuum 64 mm od shell with 3 dome screw, vivacity-e 36 mm id, delta ceramic head size 36 mm + 0.There was 10 cc effusion of the hip, which was collected and sent for cobalt and chromium levels.Cobalt level of the right hip fluid was 150 ppb and chromium was 170 ppb.There was friable synovitis with grey-brown areas.The acetabular component was well positioned and soundly ingrown.Frozen section report by pathology called into the room notable for some pmns but below criteria for infection with prominent lymphocytic and tissue necrosis c/w adverse reaction to metallic debris.Fda safety report id # (b)(4).

• Brand Name: WRIGHT MEDICAL TECHNOLOGY CONSERVE PLUS HIP RESURFACING
• Type of Device: PROSTHESIS, HIP, FEMORAL, RESURFACING
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 9410921
• MDR Text Key: 169801588
• Report Number: MW5091422
• 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: 12/02/2019
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• 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; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73