(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10: associated products: item number: 154925, item name: oxford ph3 cementless fem sz s, item lot: unknown item number: 154915, item name:oxf ph3 cementless tib sz b lm, item lot: unknown no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product lot number being provided.Review of complaint history identified additional similar complaints for the reported item.As the lot number is unknown, an additional review could not be performed.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Device is used for treatment.Radiographs were provided and reviewed by a health care radiologist.Impressions are narrowing of the medial compartment noted on images acquired at and after 08/09/2021 which is suggestive of nonspecific disruption or wear of the polyethylene lining in this region.This results in narrowing of the medial compartment joint space.Medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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