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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Myocardial Infarction (1969)
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Event Date 05/23/2022 |
Event Type
Injury
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Event Description
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It was reported that a clinical study patient underwent a left total hip arthroplasty.Subsequently, the patient experienced a myocardial infarction 14 days postop.Patient had 4 stents placed.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).D10: cat# 650-0661, lot# 3107661,delta ceramic fem hd 36/0mm.Cat# 010000666, lot# 7128460, g7 pps ltd acet shell 58g.Cat# 51-104180, lot# 6966785, tprlc 133 t1 pps ho 18x156mm.G2: foreign: netherlands.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.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Side effects of the administration of anesthesia are a known cause of chest pain, ekg changes, and myocardial infarction (heart attack) during the intraoperative and postoperative recovery.Elective total joint patients typically have a cardiac workup prior to surgery to assess the patient¿s physical readiness for surgery, hence reducing their risk for these cardiac related complications.Patients are at the highest risk immediately post op but continue to be at risk for several weeks after the procedure.As the reported complaint indicated, a cardiac postoperative complication developed two weeks postop, necessitating medical treatment to preclude further deterioration.The medical records also indicate that four cardiac stents were required which are placed due to narrowing of the vessels to treat atherosclerosis or plaque build up in the vessels which cause the narrowing and indicate underlying comorbidities prior to the procedure.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 information at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Event Description
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It was reported that a clinical study patient underwent a left total hip arthroplasty.Subsequently, the patient experienced a myocardial infarction 14 days postop and underwent angioplasty with placement of 4 cardiac stents.At the next follow up two days later, the patient was doing well with no further cardiac complications.There is no additional information available at the time of this report.
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Search Alerts/Recalls
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