This follow-up report is being submitted to relay additional information.A revision surgery was performed, where the implants were removed and replaced with a spacer, therefore the complaint is confirmed.No products were returned, therefore no visual inspections or functional testing could be conducted.No x-rays, scans, or photos were provided.The devices were implanted (b)(6), 2014 and explanted (b)(6) 2019.It was reported that the patient had a pristine device, perfect screw position, and a good fit.The device had a little bit of fibrous tissue and granuloma around prosthesis indicative of an allergic reaction.The most likely underlying cause of the complaint is due to a patient condition.There was no allegation made against the implants themselves.This is the only complaint regarding a revision surgery to replace the implant due to allergic reaction and pain for this mandible (item# 24-6551, lot# 461850a) and fossa (item# 24-6561, lot# 417370c) component.The non-conformance database (tipqa) was reviewed no non-conformances were found.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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