MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW; PROSTHESIS KNEE

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	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned because it was discarded.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression wound concerns or non-healing wound would imply that the appearance of the wound deviates from what a surgical wound should appear as.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.I&d (incision and drainage)is a procedure that can be performed under local anesthesia, as well as general sedation, depending on where it is performed and how deep surgeon anticipates he will need to explore the wound.The i&d is used to open the wound and drain any type of fluid, exudate or hematoma and to promote the wound to heal.As the wound was noted as non-healing, draining and required a poly exchange, it can be implied that the wound is symptomatic for possible deep post-operative infection, which is causing the drainage and non-healing wound.The reported event of superficial infection <30 days occurred post implantation.Superficial infections occurring <30 days from implantation are considered a procedure related complication as no device has been reported as revised.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.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations, further eliminating the implanted devices as a potential source for the reported infection.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.As device has not been indicated as revised and 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.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 one month post implantation due to infection.Articular surface prosthesis was revised.Attempt for further information has been made, but no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The root cause remains unchanged.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW
• Common Device Name: PROSTHESIS KNEE
• 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: 10685170
• Report Number: 0001822565-2020-03498
• Device Sequence Number: 16219249
• Product Code: JWH
• UDI-Device Identifier: 00889024211926
• UDI-Public: (01)00889024211926(17)261031(10)64173272
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K991581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 07/18/2022

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: 00596403220
• Device Lot Number: 64173272
• 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: 09/28/2020
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 102 KG