Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032)
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Event Date 02/18/2018 |
Event Type
Injury
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Event Description
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It was reported patient underwent a manipulation one months post implantation due to pain and bend in knee.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: product id: articular surface fixed bearing cruciate retaining (cr), catalog #: 42522000513, lot #: 63608349; product id: femur cemented cruciate retaining (cr), catalog #: 42502606402, lot #: 63829153; product id: tibia cemented 5 degree stemmed right size e, catalog #: 42532007102, lot #: 63776388; product id: palacos r 1x40 single, catalog #: 00-1112-140-01, lot #: 86494598.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2022-03338.(b)(4).Concomitant medical products: product id: articular surface fixed bearing cruciate retaining (cr), catalog #: 42522000513, lot #: 63608349; product id: all-poly patella cemented 32 mm diameter, catalog #: 42540200032, lot #: 63854106; product id: tibia cemented 5 degree stemmed right size e, catalog #: 42532007102, lot #: 63776388; product id: palacos r 1x40 single, catalog #: 00-1112-140-01, lot #: 86494598.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2022-03338, and 3007963827-2022-00332.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.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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