Concomitant medical products: unknown liner; catalog#: unknown; lot#: unknown.
Unknown head; catalog#: unknown; lot#: unknown.
Unknown stem; catalog#: unknown; lot#: unknown.
Therapy date: unknown.
The manufacturer did not receive x-rays, or other source documents for review.
As no lot number was provided, the device history records could not be reviewed.
A cause for this specific event cannot be ascertained from the information provided.
As soon as supplemental information becomes available an updated report will be submitted.
(b)(4).
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