ZIMMER BIOMET PINNACLE PFS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/13/2021 |
Event Type
Injury
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Event Description
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Pinnacle pfs alleges continue to have chronic pain in groin, hip, buttocks and back.Plaintiff had limited aol after first revision.Ppf and medical records have no information provided.Biomet cup, liner and bone screw were used with depuy head and stem.Original implant date (b)(6) 2016.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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