MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM BEARING 28X50MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issue identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.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
It was reported that the patient underwent a revision procedure 1 week post implantation due to infection.All devices were removed and replaced with competitor cement spacers.No further event information available at the time of this report.
Event or Problem Description
Upon reassessment of the reported event of a deep infection which occurred <90 days post implantation, a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.This event is no longer considered reportable and the initial report should be voided.
Additional Manufacturer Narrative
Upon reassessment of the reported event of a deep infection which occurred <90 days post implantation, a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.This event is no longer considered reportable and the initial report should be voided.

• Brand Name: VIVACIT-E DM BEARING 28X50MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12205291
• Report Number: 0001822565-2021-02034
• Device Sequence Number: 19592083
• Product Code: LPH
• UDI-Device Identifier: 00889024572737
• UDI-Public: (01)00889024572737(17)251018(10)64782922
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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 Expiration Date: 10/18/2025
• Device Model Number: N/A
• Device Catalogue Number: 110031015
• Device Lot Number: 64782922
• 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: 07/06/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAT#: 650-1066 BIOLOX HEAD LOT#: 2959151.; UNKNOWN BIOMET CUP.; UNKNOWN BIOMET LINER.; UNKNOWN BIOMET STEM.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male