(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00722.0001825034-2024-00723.0001822565-2024-00917.D10: cat #: 010000662 / g7 pps ltd acet shell 50d / lot #: 7067118.Cat #: 51-101050 / tprlc 133 fp type1 pps ho 5.0 / lot #: 3799117.Cat #: 30103204 / g7 vit e neutral lnr 32mm d / lot #: 64922381.Cat #: 650-1162 / delta cer fem hd 32/0mm t1 / lot #: 3084053.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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(b)(4).This follow-up report is being submitted to relay additional information.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 postop 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, 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 their full potential.Patient can experience a decrease with overall adls, rom 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.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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