DEPUY ORTHOPAEDICS INC US SROM*STM ST,30+4L NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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Model Number 56-3516 |
Device Problem
Use of Device Problem (1670)
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Patient Problems
Cyst(s) (1800); Pain (1994); Synovitis (2094); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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On (b)(6) 2000, the patient had a right press-fit arthroplasty to address pain, discomfort and stiffness secondary to osteoarthritits/labral calcification.Depuy components, including srom stem/sleeve were used during this procedure.Two screws were placed.Medical records from (b)(6) 2021 note the patient has been experiencing right hip instability.On (b)(6) 2021, the patient had a revision right total hip to address failed right total hip arthroplasty, secondary to eccentric polywear with polyethylene synovitis and recurrent subluxation.Depuy components were used during this procedure.The indications for surgery included pain and ¿probably has some impingement with secondary poly wear.¿ the surgeon reported finding eccentric polywear, with synovitis.The stem and cup had less than optimal anteversion and were revised.A cyst was noted in the iliopsoas tendon sheath and was debrided.Depuy components were implanted during this procedure.Date of implantation: (b)(6) 2000, date of revision: (b)(6) 2021, (right hip).
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Provided x-ray images have been reviewed.With regard to the femoral stem there is nothing indicative of a product problem identified.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : there is no evidence to suggest product error in material or manufacturing was a factor in the need for revision surgery after more than 20 years implanted.A manufacturing records review (mre) will not be performed even when lot code is known.
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