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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MODULAR FEMORAL CO-CR HEAD 48 MM DIAMETER PROSTHESIS, HIP, HEMI, FEMORAL METAL

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SMITH & NEPHEW, INC. MODULAR FEMORAL CO-CR HEAD 48 MM DIAMETER PROSTHESIS, HIP, HEMI, FEMORAL METAL Back to Search Results
Catalog Number 74122546
Device Problems Corroded (1131); Crack (1135); Noise, Audible (3273)
Patient Problems Cyst(s) (1800); Inflammation (1932); Pain (1994); Discomfort (2330); Toxicity (2333)
Event Date 02/01/2018
Event Type  Injury  
Event Description
Pt: (b)(6); on (b)(6) 2009, the pt underwent a left total hip arthroplasty. This procedure was indicated for osteoarthritis secondary to avascular necrosis of the left femoral head, which developed following a femoral head fracture from a fall down the stairs in 2005, and that fracture was surgically reduced at that time. However, the reduction did not take resulting in avascular necrosis and hip replacement. The chart-stik labels indicate that her implant was a smith & nephew bhr acetabular cup with impactor formerly mmt part no: 120152 porocast hap coated co-cr 52mm diameter, ref no: (b)(4), lot no: 090685, exp date: 07/01/2013, modular femoral co-cr head 48mm diameter, ref no: (b)(4), lot no: 08jw18803, exp date: 09/01/2013; size 8 high offset anthology porous stem, ref no: (b)(4), lot no: 06fm14426, exp date: 06/01/2016; and a modular head sleeve 12/14 taper +4mm co-cr ref no: (b)(4), lot no: 09hw24565, exp date: 08/01/2014. The surgeon notes in the operative report that, "the pt did have a small crack from the calcar; therefore, one cable was placed in the calcar region. " she notes that while the hip was improved, she was never able to sleep on the left side since the replacement due to discomfort. In (b)(6) of 2017, she began a new job that required spending several hours a day on her feet and walking frequently, which she began noticing was causing some left hip pain. She was beginning to have difficulty pulling her tights on due to left hip flexion weakness and pain. She began noticing grinding noise in the left hip with hip flexion when she would get up from sitting and with climbing stairs. She reports no trauma nor significant injury. In (b)(6) of 2018, she decided to be evaluated for grinding and pain at the left birmingham total hip arthroplasty. She described a constant aching pain in the left groin area and the lateral hip area even when at rest and she noted pain in the posteriolateral left hip area with activity. Her cobalt and chromium levels were extremely elevated. On (b)(6) 2018, she underwent a metal suppression mri of the left hip, which showed a pseudotumor (both labs and mri described in detail under relevant tests due to character limitations of this report). On (b)(6) 2018, the left birmingham total hp arthroplasty was revised for pain and grinding with a large cystic pseudotumor, elevated urine and blood cobalt levels, and new symptom of mental fogginess and forgetfulness suggesting possible cobalt toxicity. Her medical insurer would not approve an fdg pet brain stud to elucidate a diagnosis regarding her neurological condition. Revision implant consisted of a zimmer tm revision socket shell diameter 56, 6 screws tip for the shell, cemented face-changing socket liner 32 id, smith & nephew oxinium head 32mm diameter +8mm length, the cement for the socket liner was 1 batch simplex with 1 gram added vancomycin. The old stem was found to be sound and in about 15 degrees of anteversion; the trunnion and head bore showed evidence of gross corrosion. The metal on metal bearing did not show overt wear. There was no lysis about the femoral component. The acetabular component was in optimal position, not loose, and there was moderate lysis around it. The posterior capsule was fine, but the anterior capsule was thickened consistent with adverse reaction to metal debris (armd), the abduction tendons were intact, and the trochanteric bursa was not effused. There was moderate metallosis with gray-staining of the synovium which was hypertrophic also consistent with armd. Fluid was collected from the left hip and the cobalt level of the left hip fluid as 5,400 mcg/l and the chromium level of the left hip fluid was 4,600 mcg/l. Pathology report of frozen section of the left hip pseudo capsule and synovium indicated fibrinous exudate, fibrosis, chronic inflammation, and perivascular chronic inflammation consistent with alvl. Please see other relevant history for details regarding her f/u and improvement. Fda safety report id# (b)(4).
 
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Brand NameMODULAR FEMORAL CO-CR HEAD 48 MM DIAMETER
Type of DevicePROSTHESIS, HIP, HEMI, FEMORAL METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
MDR Report Key9596166
MDR Text Key175702315
Report NumberMW5092291
Device Sequence Number2
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/13/2020
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number74122546
Device Lot Number08JW18803
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/15/2020 Patient Sequence Number: 1
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