(b)(4).No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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"literature article entitled, ¿the outcome of 69 recemented hip femoral prostheses performed by one surgeon 22-40 years ago¿ by kalliopi i.Lampropoulou-adamidou, md, msc, phd, et al, published by the journal of arthroplasty (2016), vol.31, pp.2252-2255, was reviewed.The purpose of our study was to present the long-term data for 65 recemented femoral prostheses, performed by the same surgeon 22-40 years ago, to be used as a benchmark with which to compare other methods of revision of failed cemented femoral components.Implanted depuy products: cemented charnley polyethylene cup and stem and unknown femoral head.The cement used is manufactured by a competitor.The article reviews outcomes for charnley implants between the years 1976-1994.It is unknown how many adverse events and patient harms are attributed to charnley implants after they became depuy products in 1990.Results: 31 reports of osteolysis identified on serial radiographic studies- treatment unspecified.1 peroneal nerve palsy treated surgically with tendon transfer.2 stem revisions due to fracture of the implant.11 stem revisions due to aseptic loosening.There is insufficient information within the text of the article to attribute the loosening to the stem cemented with competitor cement.3 periprosthetic femoral fractures.2 treated with stem retention and orif and 1 treated with stem revision.2 dislocations: 1 converted to resection arthroplasty and 1 treated with closed reduction under anesthesia.4 infections treated with resection arthroplasty there were noted patients with pain and walking difficulty that the authors attributed to advancing age, loosened stems, and patient comorbidities.The authors did not attribute the pain and walking difficulty to the tha components.Captured in this complaint: charnley cup: implant dislocation.Unknown head: implant dislocation.Charnley stem: implant fracture post-op.Patient harms: osteolysis, infection, periprosthetic fracture post-op, nerve injury, surgical intervention, medical device removal.".
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