MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL NC; PROSTHESIS HIP

Catalog Number	192010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Confusion/ Disorientation (2553); Convulsion/Seizure (4406)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part # 010000662/ g7 shell/ lot # 6886705; part # 30103204/ liner/ lot # 64922381; part # 00625006530/ bone screw/ lot # j6853661; part # 12-115114/biolox head/ lot # 2983185.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00778, 0001825034 -2021 -00787, 0001825034 -2021 -00789.
Event or Problem Description
It was reported the patient underwent a total hip arthroplasty.Immediately post-operative the patient experienced a possible seizure.Patient had to be intubated and transferred to icu.Post-op day-3, patient was extubated but remained confused and disoriented.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Medical records were reviewed by hcp: this patient was reintubated postop due to suspicion of seizure activity due to confusion and change in orientation from preop levels.Seizure activity was ruled out, and the patient was extubated postop day three but remained confused and disoriented.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Facilities have discharge criteria that patients must meet post surgical procedure.If the discharge criteria are not met, then the patient will be kept until they are stable for discharge, and for their safety.The delayed/prolonged hospitalization is not abnormal, as side effects from anesthesia are common and typically resolve within 24-48 hours.The prolonged altered mental status after extubation is also likely the result of medications used for continuous sedation while intubated for patient safety.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ECHO POR FMRL NC
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11506817
• Report Number: 0001825034-2021-00788
• Device Sequence Number: 14478534
• Product Code: LPH
• UDI-Device Identifier: 00887868260414
• UDI-Public: (01)00887868260414(17)280823(10)835490
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K063002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 192010
• Device Lot Number: 835490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Weight: 77