Model Number 01.26.2848MHC |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/30/2023 |
Event Type
Injury
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Event Description
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The patient came in complaining of a leg length discrepancy and the cause is unknown.At about 1 year and 2 months post primary, the surgeon revised the head and liner.The surgery was completed successfully.
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Manufacturer Narrative
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Batch review performed on 13 june 2023: lot 2116151: (b)(4) items manufactured and released on 12-jan-2022.Expiration date: 2026-12-21.No anomalies found related to the problem.To date, 154 items of the same lot have been sold without any similar reported event in the period of review.Other device involved: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot 2113556: (b)(4) items manufactured and released on 13-dec-2021.Expiration date: 2026-11-23.No anomalies found related to the problem.To date, 131 items of the same lot have been sold without any similar reported event in the period of review.
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Search Alerts/Recalls
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