Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combination since its release to distribution.The search and/or review of device history records were not possible against the unknown product.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.
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