MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 12 MM HEIGHT; 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); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a arthroscopy of right knee with lysis of adhesions approximately two months post implantation.Physical therapist noticed passive patellar mobilization and range of motion was limited in right knee post knee replacement.Stiffness and arthrofibrosis of right knee were noted.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-00531, 0002648920-2022-00038, 0001822565-2022-00532, 0001822565-2022-00533, 0001822565-2022-00534.Medical product: stem extension tapered cemented 14 mm diameter +75 mm length, item# 42560007514, lot# 64653855.All poly patella cemented 35 mm diameter item# 42540000035 lot# 64621002.Femur cemented standard right size 9 item# 42504606602 lot# 64607977.Stem extension tapered cemented 14 mm diameter +75 mm length, item# 42560007514 lot# 64653780.Tibia fixed cemented right size f stem extension use required, item# 42542007502 lot# 64334590.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 a patient underwent an arthroscopy to remove scar tissue with knee manipulation due to limited flexion approximately five months post implantation.No implants were exchanged, no complications.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.It was reported a patient had a right total knee arthroplasty.Subsequently, approximately two months later, underwent a manipulation due to lysis of adhesions and limited range of motion.There are no allegations of device failure or surgical complications, and the device remains implanted without complications.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 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: ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 12 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13550446
• Report Number: 3007963827-2022-00047
• Device Sequence Number: 14711593
• Product Code: JWH
• UDI-Device Identifier: 00889024240964
• UDI-Public: (01)00889024240964(17)270930(10)64321258
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 06/09/2022

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: 42521400712
• Device Lot Number: 64321258
• 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: 02/15/2022; 06/06/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/03/2022; 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 134 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White