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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

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 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.

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 Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

• Brand Name: FLUTED STEMMED TIBIAL COMPONENT SIZE 2
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11321100
• MDR Text Key: 231586873
• Report Number: 0001822565-2021-00360
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024227071
• UDI-Public: (01)00889024227071(17)270430(10)63645293
• Combination Product (y/n): N
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Weight: 90