Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Claim letter received via email.Claim letter alleges that the patient has an enlargement in the groin area of unknown origin, elevated chromium and titanium levels, worry and concern.The claim letter has indicated that the claimant received both the asr xl and the asr resurfacing implants.This complaint record will capture the asr xl implants.Doi: (b)(6) 2009; dor: scheduled on (b)(6) 2020 (unknown hip).
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