STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_TRITANIUM 58MM SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_JR |
Device Problem
Insufficient Information (3190)
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Patient Problems
Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)
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Event Date 02/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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A non-stryker user surgeon reached out to me from a teaching facility in my territory asking me if a femoral head component that he revised over a year ago was a part of lfit v40 recall from dates 2011-2016.After looking up the product number and lot code with my sales manager through our resources, the item in question was determined to not be a part of the recall.He reported trunnion wear and adverse tissue reactions.Informed me that he revised the femoral and acetabular components to another companies implants and disposed of the implants removed.Update 02/july/2020 wg: an arthroplasty today article (issue 6 (2020) 210-213), "taper fretting corrosion with stryker anato stem after hip replacement cites a case study of a patient's right hip." as noted in the article: ".Developed worsening right hip pain.He complained of groin pain in the right hip and was unable to use an exercise bicycle or walk for more than 5-10 minutes.Acetabular component was in good alignment, but there was lucency noted in the superolateral aspect of the acetabular bone-implant interface in zone 1, potentially concerning for loosening.There was no evidence of polyethylene wear.Cobalt ion levels were 6ppb (normal <1.8 ppb).Fluid collection consistent with an altr.Mechanical defects of both the femoral neck with notching and mechanical defects of both the femoral neck and inner taper of the prosthetic metal head.The acetabular component was loose." patient was revised to a competitor construct.
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Search Alerts/Recalls
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