(b)(4).Age: (b)(6).Medical product: catalog #: 110030401, prx hum hi plt rt 4h 90mm, lot # unknown; catalog #: 110025332, 3.2mm pegs 32mm, lot # unknown; catalog #: 110025332, 3.2mm pegs 32mm, lot # unknown; catalog #: 110025338, 3.2mm pegs 38mm, lot # unknown; catalog #: 816135034, 3.5mm cort lock scr 34mm ns, lot # unknown; catalog #: 816135048, 3.5mm cort lock scr 48mm ns, lot # unknown; catalog #: 816135052, 3.5mm cort lock scr 52mm ns, lot # unknown; catalog #: 110017724, screw t15 lp cort 3.5x24mm ns, lot # unknown; catalog #: 110017726, screw t15 lp cort 3.5x26mm ns, lot # unknown; catalog #: 110017728, screw t15 lp cort 3.5x28mm ns, lot # unknown; catalog #: 110018050, screw t15 md 3.5x50mm ns, lot # unknown; catalog #: 110018054, screw t15 md 3.5x54mm ns, lot # unknown; catalog #: 110018058, screw t15 md 3.5x58mm ns, lot # unknown; catalog #: 816140030, 4.0mm canc lock scrw 30mm, lot # unknown; catalog #: 816140034, 4.0mm canc lock screw 34mm, lot # unknown; catalog #: 816140046, 4.0mm canc lock screw 46mm, lot # unknown; catalog #: 816140050, 4.0mm canc lock scrw 50mm, lot # unknown; catalog #: 816140055, 4.0mm canc lock screw 55mm, lot # unknown.Report source: canada.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02342, 0001825034-2022-02345, 0001825034-2022-02346, 0001825034-2022-02347, 0001825034-2022-02348, 0001825034-2022-02349, 0001825034-2022-02350, 0001825034-2022-02351, 0001825034-2022-02352, 0001825034-2022-02353, 0001825034-2022-02355, 0001825034-2022-02356, 0001825034-2022-02357, 0001825034-2022-02358, 0001825034-2022-02359, 0001825034-2022-02360, 0001825034-2022-02361, 0001825034-2022-02362.
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This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10 corrected: g2 no product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: slight gap noted between the proximal metallic plate and the lateral cortex of the proximal humerus at the level of the greater tuberosity.Several screws at appear at the margin or extending past the margin of the glenohumeral joint space.Overall fit and alignment of the implants appears normal, although several screws appear closely approximated with the joint space.Osteonecrosis and potential for screw migration could not be confirmed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: eighteen-month follow-up visit - moderately severe malunion (collapse of greater tuberosity escape) reassessed - very limited range of motion which has been ongoing since injury/surgery - ap and lateral x-rays performed: stable appearance of plate and screw fixation compared to previous with severe degenerative change of the glenohumeral joint consultation - diagnosis: r shoulder avascular necrosis (avn) joint orif proximal humerus junction with at least two screws penetrating joint device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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