Batch review performed on 02 jul 2019: 2 device of lot 161346 involved in this complaint: (b)(4) items manufactured and released on 24-oct-2016.Expiration date: 20-04-2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Two items are present in this complaint with the same lot number.Visual inspection performed by medacta washing & packaging manager: the two items received (femoral augmentation distal) were visually inspected on july 23rd 2019.The event has been confirmed.The packaging of one item was completely opened while the second item packaging was still closed (primary and secondary sterile barrier).Both items presented, into the primary packaging, some white parts of debris probably came from the primary tyvek that was damaged due to the contact with screw and augment.In addition, the primary plastic blister was scratched and in only one item also broken at the corner, these probably due to extreme shipping and handling conditions.The root cause likely relates to the combined factors of anomalous shipping/handling conditions.This is the first event reported on femoral augmentation; no action is at the moment foreseen.
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