(b)(4).The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Wiater, j.Michael (2017) "exploring failure of total shoulder arthroplasty systems through implant retrieval, radiographic, and clinical data analyses" journal of shoulder and elbow arthroplasty, volume 1: 1¿10.Unknown if bio-modular or comprehensive shoulder system.Initial reporter - the article was written by drew d moore, md, james e moravek, md, erin a baker, phd, meagan r salisbury, ms, kevin c baker, phd and j michael wiater, md at hospitals/universities department of orthopaedic surgery, beaumont health, royal oak, michigan department of surgery, oakland university william beaumont school of medicine, rochester, michigan, department of orthopaedic research, beaumont health, royal oak, michigan.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.Both legacy biomet and legacy zimmer, along with competitor products, are mentioned in this journal article.It is unclear which complications are tied to what systems.Please see associated reports: 0001822565-2017-04410, 0001822565-2017-04411, 0001825034-2017-04291, 0001825034-2017-04292, 0001825034-2017-04293.
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