(b)(4).D10 - concomitant devices - persona revision cemented fixed tibial tray left size f catalog #: 42542007501 lot #: 64599642, persona revision offset splined uncemented stem extension 3mm x 13mm x +135mm catalog #: 42560313513 lot #: 64799465, persona revision cemented femoral component plus left size 9+ catalog #: 42504606611 lot #: 64857996, persona revision cemented distal femoral augment size 9, 9+ 5mm catalog #: 42556606605 lot #: 64882498, persona revision cemented distal femoral augment size 9, 9+ 5mm catalog #: 42556606605 lot #: 64799265, persona revision cemented distal femoral augment size 9, 9+ 5mm catalog #: 42556606605 lot #: 64769986, persona revision constrained condylar knee left 16mm catalog #: 42512800716 lot #: 64615633, persona revision offset splined uncemented stem extension 6mm x 18mm x +135mm catalog #: 42560613518 lot #: 64769916, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 942aaa2510, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 942aaa2510, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 936bae2505.The device history records were not reviewed as the reported event was not related to the zimmer biomet device.Bursitis is the inflammation or irritation of the bursae (the fluid filled sac that cushions the joint) and is typically caused by repetitive motion, overuse, and pressure to the bursae.Bursitis is a very common condition that can impact any of the joints and can last for a short duration or years.Symptoms the patient can experience include pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.Conservative treatment consists of over the counter (otc) medications pain relievers and anti-inflammatories, rest, ice, elevation, and applying pressure wraps.If conservative treatments fail, physical therapy, aspiration, arthroscopy, or steroid injections may be necessary.The complaint indicates that post-operative bursitis developed and required medical intervention for treatment.Tendonitis is the inflammation or irritation of the tendons and is typically caused by repetitive motion, overuse and pressure to the bursae.Symptoms the patient can experience include pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.This can impact the patients¿ ability to use the joint to its full potential.Patients can experience a decrease with overall activities of daily living, range of motion of the joint, decrease in quality of life, as well as increasing the need for possible over the counter (otc) medications for swelling and pain control.Treatment for tendonitis can consist of otc medications, such as tylenol and anti-inflammatories, prescribed pain medications, physical therapy, rest, ice, elevating the affected joint and steroid injections.Based on the information provided, the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2024-00684, 0001822565-2024-00685, 0001822565-2024-00686.H3 other text : event unrelated to zimmer biomet product.
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