MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD NITRIDED; PROSTHESIS, 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); Ambulation or Postural Difficulties (2544)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Subsequently, the patient had an arthroscopy with lysis of adhesions approximately 10 months later due to arthrofibrosis, stiffness, pain, difficulty walking, and adls.The patient's issues resolved approximately 2 weeks later.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 42532007102 - tibia cemented 5 degree stemmed right size e - 64831150, 42522100810 - articular surface medial congruent (mc) right 10 mm height use with tibia sizes e-f/cr femur sizes 8-11 - 64781936, 42540000032 - all poly patella cemented 32 mm diameter - 64843478, unknown - unknown cement - unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00255, 3007963827-2022-00256, 0002648920-2022-00212.
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Subsequently, the patient had an arthroscopy with lysis of adhesions and manipulation under anesthesia for limited flexion approximately 10 months later due to arthrofibrosis, stiffness, pain, difficulty walking, and decreased adls/mobility without noted complications.Symptoms resolved approximately 2 weeks later.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.D10: unknown - unknown palacos plus gentamicin antibiotic-loaded cement - unknown.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.D10: 110034355 - refobacin bc r 1x40 us - z23aah2204.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 available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.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 available at the time of this report.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD NITRIDED
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15551508
• Report Number: 0001822565-2022-02910
• Device Sequence Number: 2984854
• Product Code: JWH
• UDI-Device Identifier: 00889024576193
• UDI-Public: (01)00889024576193(17)310113(10)64983080
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193223
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/20/2023

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: N/A
• Device Catalogue Number: 42572606602
• Device Lot Number: 64983080
• 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: 09/22/2022
• Supplement Date Received by Manufacturer: 10/10/2022; 10/13/2022; 01/20/2023
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 10/11/2022; 10/13/2022; 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H10.; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: White