(b)(4).D11 - medical product: catalog #: 211h6032, 6.0mm dia x 32.5mm vbt assy, lot # unknown; catalog #: 204h0300, 300mm vbt cord, lot # unknown; catalog #: 211h6535, 6.5mm dia x 35mm vbt assy, lot # unknown; catalog #: 211h6035, 6.0mm dia x 35mm vbt assy, lot # unknown; catalog #: 211h6035, 6.0mm dia x 35mm vbt assy, lot # unknown; catalog #: 211h6035, 6.0mm dia x 35mm vbt assy, lot # unknown; catalog #: 203h0012, 12mm vbt anchor, lot # unknown; catalog #: 203h0012, 12mm vbt anchor, lot # unknown; catalog #: 203h0012, 12mm vbt anchor, lot # unknown; catalog #: 203h0012, 12mm vbt anchor, lot # unknown; catalog #: 203h0012, 12mm vbt anchor, lot # unknown; catalog #: 203h0012, 12mm vbt anchor, lot # unknown; catalog #: 203h0012, 12mm vbt anchor, lot # unknown; catalog #: 211h6030, 6.0mm dia x 30mm vbt assy, lot # unknown; catalog #: 211h6027, 6.0mm dia x 27.5mm vbt assy, lot # unknown.Reported event was unable to be confirmed due to limited information received from the customer.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 could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Remains implanted.
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