MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA FIXED CEMENTED LEFT SIZE F STEM EXTENSION; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00513, 0001822565-2022-00514, 0001822565-2022-00515, 0001822565-2022-00516, 0001822565-2022-00518, 0001822565-2022-00519, and 0001822565-2022-00520.Concomitant medical products: medical devices: femur cemented plus left size 7+ catalog# 42504606211, lot#: 64440094; stem extension straight splined uncemented 22 mm diameter +135 mm length catalog#: 42560113522, lot#: 64559285; femoral central cone size medium catalog#: 42545001012, lot#: 64189936; femoral distal augment cemented size 7, 7+ 10 mm thickness catalog# 42556606210, lot#: 64475637; articular surface fixed bearing constrained condylar knee (cck) left 12 mm height catalog# 42512800712, lot#: 64316030; stem extension 6mm offset splined uncemented 18 mm diameter +135 mm length catalog#: 42560613518, lot#: 64514980; tibial central cone size small catalog# 42545000511, lot#: 64470027.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 had onset of pain and swelling approximately six months post- implantation.The issues were noted to be resolved after oral steroids and anti inflammatory medication.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b3, b4, b5, b7, g3, g6, h2, h6, and h10.
Event or Problem Description
It was reported that patient had onset inflammation and iliotibial band friction approximately nine months post implantation.The issues were noted to be resolved after oral steroids, topical cream, and formal physical therapy.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.It was reported the patient was experiencing symptoms from it (iliotibial band) friction (rubbing) and was treated conservatively with physical therapy, oral steroid and topical cream to the site.The iliotibial band is a multiple joint structure that originates at the tuberculum tubercle of the iliac crest and inserts at the anterolateral (gerdy) tubercle of the lateral condyle of the tibia.During a total knee procedure, the iliotibial band is pulled in excess laterally for a prolonged period of time to allow implantation of the devices.The pulling on the band leads to tissue lengthening and increased inflammation of the iliotibial band while maintaining integrity of the ligament.As the iliotibial band heals, the fibers can become fibrotic leading to scar tissue at the distal iliotibial band.Often resulting in a fixed state of the tissue producing pain at the knee.Treatment options for a tight it band, conservative physical therapy which would include site specific mobilization and stretching or more invasive approach of surgical intervention to release the iliotibial band tightness.This signifies a complication post implantation that is associated with the procedure.It was further reported that the patients symptoms associated with it band resolved with the conservative treatment provided and remains implanted to date.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint for swelling/edema has been confirmed by review of medical records.The complaint of pain is subjective and was unable to be confirmed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pes anserinus bursitis and iliotibial band friction, x rays showed no lysis, loosening, or wear.Device history record was reviewed and no discrepancies relevant to the reported event 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.

• Brand Name: TIBIA FIXED CEMENTED LEFT SIZE F STEM EXTENSION
• 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: 13551513
• Report Number: 0001822565-2022-00517
• Device Sequence Number: 5037019
• Product Code: JWH
• UDI-Device Identifier: 00889024562806
• UDI-Public: (01)00889024562806(17)290430(10)64334583
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/22/2022

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: 42542007501
• Device Lot Number: 64334583
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 02/23/2022; 06/01/2022; 06/17/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/21/2022; 06/10/2022; 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• 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: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 114 KG