MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. VERSYS FEMORAL STEM CEMENTED REVISION/CALCAR 12/14 NECK TAPER SIZE 13 250MM; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/10/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient underwent an initial hip procedure on an unknown date using a competitor's implants.Subsequently, the patient was revised for a periprosthetic fracture.During the revision hemi arthroplasty surgery, the patient's condition deteriorated, and the patient died of cardiopulmonary arrest.It is not known whether the patient had any underlying medical conditions that may have been related to the event.The patient's cardiopulmonary arrest occurred after the bone cement and stem were inserted into the patient.The cement is a competitor product.The cause of the cardiopulmonary arrest was not determined; however, no causal relationship between the death and the product has been noted.There was no patient information or medical records available.Though requested, no additional information was available.
Additional Manufacturer Narrative
(b)(4).D10: cat# unknown lot# unknown depuy bone cement g2: foreign: country: japan no product was returned for evaluation.It was reported that a competitor product was being revised in a hip procedure.After competitor cementation and stem insertion, the patient's cardiac condition deteriorated leading to cardiac arrest without resuscitation.The patient's age and comorbid conditions remain unknown.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Side effects of the administration of anesthesia are a known cause of cardiac stress during the intraoperative and postoperative recovery.Most patients with a cardiac history will have a cardiac workup prior to clear them for surgery to demonstrate the patient's cardiac status is fit to withstand the stress of anesthesia, positioning, and surgery.As the reported complaint indicated, a cardiac complication developed intraoperatively, but any further intervention was insufficient to prevent the terminal outcome.As the reported event was unrelated to the implanted stem, a review of the device history records was not performed.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.

• Brand Name: VERSYS FEMORAL STEM CEMENTED REVISION/CALCAR 12/14 NECK TAPER SIZE 13 250MM
• Common Device Name: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20300079
• Report Number: 0002648920-2024-00298
• Device Sequence Number: 7792434
• Product Code: JDI
• UDI-Device Identifier: 00889024140042
• UDI-Public: (01)00889024140042(17)321003(10)65550751
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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 Model Number: N/A
• Device Catalogue Number: 00787101362
• Device Lot Number: 65550751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown