MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E; PROSTHESIS, HIP

Catalog Number	110031013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	10/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10: cat# 01.06010.206 lot# 3229369 avenir std stem cemented 6, cat# 00223200418 lot# 66323544 cerclage cable with crimp , cat# 00223200418 lot# 66081021 cerclage cable with crimp, cat# 00223200418 lot# 66722992 cerclage cable with crimp, cat# 00223200418 lot# 66108551 cerclage cable with crimp, cat# 00223200418 lot# 66053938 cerclage cable with crimp , cat# 00223200418 lot# 67283878 cerclage cable with crimp , cat# 00223200301 lot# 65749856 bone plate, cat# 00223200318 lot# 63406394 cable for bone plate , cat# 00223200318 lot# 65240136 cable for bone plate, cat# 00223200318 lot# 64438890 cable for bone plate , cat# 00223200318 lot# 65438577 cable for bone plate, cat# 00223200318 lot# 63979245 cable for bone plate, cat# 00223200318 lot# 64420727 cable for bone plate.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported one day post right hip surgery, the patient was transferred to another facility for an unknown cardiac issue.It is unknown what treatment was provided or why the patient needed to be transferred.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6; h10.The following sections were corrected: h6 component code.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 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, and medical treatment was warranted to treat the complication.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The root cause of the reported event was determined to be unrelated to the device.Complaint is not confirmed.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: VIVACIT-E
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23819367
• Report Number: 0001822565-2025-04531
• Device Sequence Number: 13287998
• Product Code: LPH
• UDI-Device Identifier: 00889024572713
• UDI-Public: (01)00889024572713(17)300708(10)67391191
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: Lay User/Patient
• Device Catalogue Number: 110031013
• Device Lot Number: 67391191
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Male