MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. SMITH AND NEPHEW METAL-ON-METAL BIRMINGHAM HIP IMPLANT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/ METAL, RESURFACING-BHR

Device Problems Corroded (1131); Mechanical Problem (1384); Noise, Audible (3273)

Patient Problems Hearing Loss (1882); Necrosis (1971); Neuropathy (1983); Pain (1994); Thrombosis (2100); Toxicity (2333); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 01/12/2017

Event Type  Injury  

Event Description

(b)(6).On (b)(6) 2010, the patient received a left tha with a smith and nephew metal-on-metal birmingham hip implant with a size 52 cup, 46 mm head with a +0 neck length and a size 4 stem.In (b)(6) of 2014, patient developed high frequency hearing loss according to an audiogram.In (b)(6) of 2014, the patient¿s echocardiogram was notable for grade 1 diastolic dysfunction."electromyelogram" and nerve conduction velocity tests were only positive for carpal tunnel syndrome and evident polyneuropathy.On (b)(6) 2015, her plasma cobalt level was 97 mcg/l and her whole blood cobalt level was 97 mcg/l, and her serum chromium level was 47 mcg/l.The patient developed audible squeaking and mechanical grinding of the left hip with regular walking.The grinding was accompanied by lateral thigh pain and some iliotibial band pain on the left side, metal suppression mri of the left hip showed lateral capsular pseudotumor and possible early involvement of the hip abductor tendons and posterior capsular thickening.Recheck of her cobalt and chromium levels on (b)(6) 2015 was notable for a urine cobalt level 1,528.5 mcg/l, whole blood cobalt of 111.0 mcg/l, urine chromium of 242.8mcg/l and a whole blood chromium of 37.4 mcg/l.The left hip was revised on (b)(6) 2017.Frozen section of left hip tissue notable for fibrous stroma with areas of necrosis and focal histiocytic infiltrates, but negative for infection.The cobalt level of the left hip was 12,000 mcg/l and the chromium level of the left hip joint fluid was 6,800 mcg/l.The revision surgeon noted marked intracapsular metallosis.There was evidence of severe corrosion at the trunnion of the stem and head bore.There was severe lysis about the acetabular component and the component was fixed and not loose.Abduction tendons and capsule were intact.The revision implant was a zimmer continuum socket diameter 56 fixed with 4 screws, vivacity e polyethylene liner, the smith and nephew stem was retained and a new smith and nephew oxonium head size +mm +12.The patient experienced a post-surgical complication of dvt at 13 days post revision surgery.On (b)(6) 2017, chromium left hip fluid, 6,800 mcg/l.Fda safety report id # (b)(4).

• Brand Name: SMITH AND NEPHEW METAL-ON-METAL BIRMINGHAM HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/ METAL, RESURFACING-BHR
• Manufacturer (Section D): SMITH AND NEPHEW, INC.
• MDR Report Key: 9558467
• MDR Text Key: 174659808
• Report Number: MW5092051
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• 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; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 75