MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLUTED STEMMED TIBIAL COMPONENT SIZE 2; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00358, 0001822565-2021-00359, 0002648920-2021-00029, 0002648920-2021-00030, and 0001822565-2021-00396.Medical devices: lps flex femoral component size e right catalog#: 00596801552 lot#: 64134680; lps-flex fixed xl e/12 10mm catalog#: 00596202410 lot#: 63297073; all-poly patella cemented 29 mm diameter catalog#: 42540200029 lot#: 64080707; taper stem plug catalog#: 00596009900 lot#: 64148879; stem extension replacement screw catalog#: 00598009000 lot#: 64217975.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 that patient is experiencing right knee pain and swelling approximately two years post implantation.No revision procedure has been reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: one month post implantation x-ray: suprapatellar effusion with prepatellar soft tissue swelling noted; five month post implantation mri: non specific findings of submillimeter lucencies of the tibial tray and mild valgus alignment with possible heterotopic bone formation vs.Subsidence of the tray without definitive changes from the baseline images, moderate edema, follow up imaging needed to make definitive diagnoses and to observe remarkable changes; patient states pain and swelling, surgeon states nothing is wrong and patient should bike; patient is medicating with nsaid rubs and pain patches, has tried physical therapy and pain management.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FLUTED STEMMED TIBIAL COMPONENT SIZE 2
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11321100
• Report Number: 0001822565-2021-00360
• Device Sequence Number: 11575054
• Product Code: JWH
• UDI-Device Identifier: 00889024227071
• UDI-Public: (01)00889024227071(17)270430(10)63645293
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2021

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: 00599602802
• Device Lot Number: 63645293
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021; 04/05/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/17/2021; 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 90