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Model Number N/A |
Device Problems
Material Too Rigid or Stiff (1544); Appropriate Term/Code Not Available (3191)
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Patient Problems
Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: stemmed tibial component precoat size 6, item # 00598004702, lot # unknown.All poly patella size 29 mm dia, item # 00597206529, lot # 63432236.Femoral component option size e, item # 00596401552, lot # 63393272.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event; please see associated reports: 0001822565-2018-06625, 0002648920-2018-00845, 3007963827-2018-00216.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported patient underwent right knee arthroplasty; subsequently patient is experiencing swelling pain, lack of mobility, stiffness, soreness, and lack of range of motion and possible bursitis.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a5, b4, b5, g3, g4, g7, h1, h2, h3, h6, h10 foreign - canada reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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