(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01732 and 0001825034-2023-01734.D10: cat# 12-115116, lot# 2970965, cer bioloxd mod hd 32mm +3 nk.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
It was reported that the patient underwent an initial right total hip arthroplasty.Subsequently, at approximately eight months post-op the patient developed persistent lateral thigh and groin pain.Tendonitis was suspected however, the surgeon also questioned if there was an issue with the press-fit femoral component.Approximately 9 months post-op, an injection of steroids and local anesthetic was given under fluoroscopic guidance.The patient has since completed the study with improvement in pain and all implants remaining in place.Attempts have been made and no further information has been provided.
|
Tendinitis is inflammation of a tendon that attaches muscle to bone.It can happen to any tendon in the body.When a tendon is inflamed, it can cause swelling, pain, and discomfort.Tendinitis often results from sports injuries or repetitive movements, it's usually caused by overuse.The condition is more common in adults over the age of 40 and athletes.With tha the hip is manipulated and tendons get stretched and pulled which can cause it to be inflamed with symptoms of swelling, pain, and discomfort.As the patient is recovering tendonitis can develop from overuse, especially within the first couple months.Tendinitis may go away over time.If not, a doctor will recommend treatments to reduce pain and inflammation and preserve mobility.Most cases of tendonitis can be successfully treated with rest, ice, compression (a sleeve or wrap), elevation, stretching, and modification of activities however tendinitis is also commonly treated with steroid injections to reduce the pain and inflammation.When properly treated, most tendinitis conditions don¿t result in permanent joint damage or disability.The best way to prevent it from occurring is to avoid or modify activities that caused the problem.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.
|