MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) STANDARD POROUS; PROTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling/ Edema (4577)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).It was reported a patient underwent manipulation under anesthesia approximately one month after 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.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00036, 0002648920-2022-00026.
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Approximately one month later, the patient underwent manipulation under anesthesia for arthrofibrosis and stiffness.The implants remained intact.It was noted that the patient continues to have limited range of motion due to scar tissue/adhesions.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Approximately one month later, the patient underwent manipulation under anesthesia for arthrofibrosis and stiffness.The implants remained intact.It was noted that the patient continues to have limited range of motion due to scar tissue/adhesions.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).It was reported a patient underwent manipulation under anesthesia approximately one month after 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.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00036, 0002648920-2022-00026.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Approximately one month later, the patient underwent manipulation under anesthesia for arthrofibrosis and stiffness.The implants remained intact.It was noted that the patient continues to have limited range of motion due to scar tissue/adhesions.Subsequently, approximately thirteen months from initial implantation, a mri indicated tibial subsidence and tibial loosening.No further interventions have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04) - femur.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: right knee aspiration, pain, swelling, and arthrofibrosis; right knee pain, arthrofibrosis, tibial subsidence, implant loosening; following mri: ambulates with antalgic gait, rom is 5 short of full extension to 95 degrees flexion.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.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: FEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) STANDARD POROUS
• Common Device Name: PROTHESIS, 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: 13499467
• Report Number: 0001822565-2022-00358
• Device Sequence Number: 17150165
• Product Code: MBH
• UDI-Device Identifier: 00889024469907
• UDI-Public: (01)00889024469907(17)310607(10)65022787
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K122745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 12/31/2024

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: 42500806402
• Device Lot Number: 65022787
• 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: 01/21/2022
• Supplement Date Received by Manufacturer: 06/05/2024; 12/30/2024
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 07/01/2024; 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White