MAUDE Adverse Event Report: SCREW, FIXATION, BONE ; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC / POLYMER

Device Problem Corroded (1131)

Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Hearing Loss (1882); Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Test Result (2695)

Event Date 02/01/2013

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2013, she underwent a right total hip arthroplasty with a size 10 reduced profemur renaissance stem, size 46 mm dynasty porous-coated shell, 6.5 x 15mm cancellous bone screw, size 28 mm +0 degrees inner diameter dynasty a class poliner, a 28mm short ceramic femoral head, and a short vv cobalt chrome modular neck.Since her arthroplasty, she has developed new fatigue, diminished resilience, hearing loss, and new autoimmune problems and allergies.In (b)(6) of 2019, she noted new symptoms of right hip pain with hip flexion against resistance and pain with hip abduction when she skis.The metal suppression mri of right hip showed subtle anterior foreign body granuloma or fluid collection.On (b)(6) 2019, urine cobalt level was 0.5 mcg/l and the blood cobalt level was less than 0.5 mcg/l.Neuroq analysis of her fdg pet brain scan showed abnormal hypometabolism involving 11 brain cluster regions in a pattern compatible with chronic toxic encephalopathy.On (b)(6) 2020, the right hip was revised to microport vv tiaiv alloy modular neck 8 and a new delta ceramic 28mm +0 head.The old stem was sound and was in about 15 degrees of anteversion, there was gross corrosion at stem end of the modular cocr neck and also metal transfer into bore ceramic head.Posterior capsule was intact, anterior capsule was thickened in typical adverse reaction to metal debris, abduction tendons were intact.Pathology report of frozen section of right hip capsule synovium notable for fibrotic synovium with an alval score of 3 out of 10.Fda safety report id# (b)(4).

• Brand Name: SCREW, FIXATION, BONE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC / POLYMER
• MDR Report Key: 9763811
• MDR Text Key: 181720890
• Report Number: MW5093329
• Device Sequence Number: 2
• Product Code: HWC
• 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: 02/24/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 57