MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 50D; PROSTHESIS HIP

Catalog Number 010000662

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Confusion/ Disorientation (2553); Convulsion/Seizure (4406)

Event Date 02/11/2021

Event Type  Injury  

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 products: part # 30103204/ liner/ lot # 64922381; part # 192010/ stem/ lot # 835490; 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 -00787, 0001825034 -2021 -00788, 0001825034 -2021 -00789.

Event 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.

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 Description

No further event information available at the time of this report.

• Brand Name: G7 PPS LTD ACET SHELL 50D
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11506812
• MDR Text Key: 240408183
• Report Number: 0001825034-2021-00778
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524217
• UDI-Public: (01)00880304524217(17)301027(10)6886705
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 010000662
• Device Lot Number: 6886705
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 77