ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING PS RIGHT 11 MM HEIGHT; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling/ Edema (4577)
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Event Date 04/05/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a knee arthroplasty.Approximately 5 months post implantation, the patient underwent manipulation under anesthesia.The patient reports she is still having swelling, no range of motion, limited mobility, and the knee is hot to the touch.The patient remains implanted with devices.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported a patient underwent a manipulation under anesthesia due to stiffness that was impacting rom from adhesions & scar tissue.Patient remains implanted.Patient reports swollen and hot to the touch with limited range of motion.One month later, knee was aspirated for recurrent pain, swelling, and warmth performed.Upon exam performed by new doctor noted effusion, mild pain with rom, tender to palpation, moderate laxity with varus/valgus stress test and anterior drawer.
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Search Alerts/Recalls
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