MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 42530006702, tibia, lot # 64102955, 42522100412, articular surface, lot # 63811402, 00587806535, patella, lot # 6425270.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00527, 3007963827 - 2020 - 00043.
Event or Problem Description
It was reported that approximately 2 months post implantation, the patient was experiencing stiffness and consequently underwent a manipulation under anesthesia with injection of the right knee.Approximately 2 weeks post manipulation, the patient's swelling had reportedly resolved.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.The following sections were update/corrected updated: b4, b5, g4, g7, h2, h3, h6 the reported event was able to be confirmed by review of the provided medical records.During the one-month post op visit, pain, swelling, and stiffness were reported.Thus, a manipulation under anesthesia was performed with injection of marcaine and depomedrol to the right knee.Review of the device history records did not identify any deviations or anomalies during manufacturing related to the reported event.Review of the instructions for use of the persona knee system identified that pain, stiffness, and limited range of motion are potential known adverse effects of the tka.However, a definitive root cause cannot 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: FEMUR TRABECULAR METAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9681152
• Report Number: 0001822565-2020-00526
• Device Sequence Number: 2668058
• Product Code: MBH
• UDI-Device Identifier: 00889024230743
• UDI-Public: (01)00889024230743
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: 42502806002
• Device Lot Number: 64278763
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 55