MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED STANDARD RIGHT SIZE 7; PROSTHESIS, KNEE

Model Number	42-5046-062-02
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a clinical study that a patient underwent a revision right total knee arthroplasty.Subsequently, approximately two months post-implantation, the patient underwent a manipulation under anesthesia due to limited flexion, stiffness, and scar tissue.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Medical product: articular surface fixed bearing constrained posterior stabilized (cps) right 12 mm height use with tibia sizes c-d / ps femur sizes 6-9: catalog#42522600512, lot#63982441; stem extension tapered cemented 14 mm diameter +75 mm length: catalog#42560007514, lot#64557017; tibial central cone size fixed tibia: catalog#42545000508, lot#64189931; tibia fixed cemented right size c stem extension use required: catalog#42542006402, lot#64295685; stem extension tapered cemented 14 mm diameter +75 mm length: catalog#42560007514, lot#64478838.Multiple mdr reports have been filed for this event, please see associated report: 3007963827-2022-00147.Customer has indicated that product will not be returned to zimmer biomet for investigation, as the products remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a5; b4; b5; b7; g3; h3; h10.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; h2; h3; h6; h10.A review of the device history records was not performed as the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.It was reported a patient underwent a manipulation approximately two months after a total knee arthroplasty.According to tabers medical dictionary ¿ manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint, with or without anesthesia.With anesthesia is (mua).Per clinical orthropaedics and related research (how to treat the stiff total knee arthroplasty? a systematic review), mua is used to treat and resolve arthrofibrosis (scar tissue).This procedure is performed to increase articular motion and reduce chronic pain from arthrofibrosis.The indication for manipulation under anesthesia is related to limited range of motion and stiffness due to adhesions/scar tissue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.H3 other text : see h10 narrative.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product: all poly patella cemented 32 mm diameter: catalog#: 42540000032, lot#: 6267038; unknown competitor bone cement: catalog#: ni, lot#: ni.Additional information provided does not alter previously reported investigation results.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 at time of this report.

• Brand Name: FEMUR CEMENTED STANDARD RIGHT SIZE 7
• 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: 14454181
• Report Number: 0001822565-2022-01486
• Device Sequence Number: 19977429
• Product Code: JWH
• UDI-Device Identifier: 00889024562561
• UDI-Public: (01)00889024562561(17)290531(10)64308793
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 42-5046-062-02
• Device Catalogue Number: 42504606202
• Device Lot Number: 64308793
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 05/18/2022; 06/09/2022; 01/25/2023
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/08/2022; 06/14/2022; 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Race: Black Or African American