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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Memory Loss/Impairment (1958); Necrosis (1971); Neuropathy (1983); Pain (1994); Swelling (2091); Shaking/Tremors (2515)

Event Date 09/29/2016

Event Type  Injury  

Event Description

On (b)(6) 2005, (b)(6) received a right tha involving a conserve plus 54/48 hip resurfacing for osteoarthritis of the right hip secondary to developmental hip dysplasia.This worked well until about (b)(6) 2015, when she started noticing progressive and limiting right hip pain especially with activity.Concurrently, she developed a fine rest tremor of her hands, peripheral neuropathy, and some mild memory issues.A metal suppression mri was made of the right hip on (b)(6) 2016, and showed some inter-capsular fluid, which tracks into the trochanteric bursa.There appeared to be an associated 4 cm by 2 cm posterior capsular enlargement consistent with pseudo-tumor.The changes appeared to be limited to the posterior lateral superior capsular area with no compromise of the hip abductor tendons.On (b)(6) 2016, her urine cobalt level was 3.9 ppb and on (b)(6) 2016, her serum/plasma cobalt level was 2.3ppb.On (b)(6) 2016, her right tha was revised to a stryker exeter stem # 37.5 # 3, 32 mm +0 delta ceramic, zimmer continuum multi-hole 60 od with dome screws, longevity constrained liner with a 32 mm id.Necrotic, thickened and inflamed peri-prosthetic tissues were debrided and repaired.Pathology report of frozen section of right tissue sample notes that the tissue was compatible with reaction to prosthesis and negative for infection and there are mild histiocytic infiltrates with less than one pmn per high power field.Cobalt level of right hip fluid was 170 ppb and chromium was 190 ppb.She reports that her neurological symptoms have gone away since her revision surgery but she did not make note of how soon after her revision that they resolved.She no longer notes numbness of the bottom of her feet.She has noticed that her little fingers have stopped trembling when at rest.She notes no more issues with forgetfulness.Fda safety report id # (b)(4).

• Brand Name: WRIGHT MEDICAL CONSERVE PLUS HIP RESURFACING
• Type of Device: PROSTHESIS, HIP, FEMORAL, RESURFACING
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 9410875
• MDR Text Key: 169829126
• Report Number: MW5091420
• Device Sequence Number: 1
• Product Code: KXA
• 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

1 Device was Involved in the Event

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: 66 YR
• Patient Weight: 82