MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 5, 5+ 5 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-00913, 0001822565-2022-00915, 0001822565-2022-00916, 3007963827-2022-00080.Medical product femur cemented standard right size 5 item# 42504605802 lot# 64541285; femoral distal augment cemented size 5, 5+ 5 mm thickness item# 42556605805 lot# 64602337; femoral central cone size medium item# 42545001012 lot# 64470406; articular surface fixed bearing (cps) right 14 mm height item# 42522600414 lot# 64525555; stem extension straight splined uncemented 14 mm diameter +135 mm length item# 42560113514 item# 64542409; tibia fixed cemented right size d stem extension use required item# 42542006702 lot# 64207430; tibial augment cemented half block right medial size cd 5 mm thickness item# 42555803405 lot# 64353978; tibial augment cemented half block right lateral size cd 5 mm thickness item# 42555803205 lot# 64333007; tibial central cone size x-small item# 42545000510 lot# 64189844; stem extension 3mm offset splined uncemented 11 mm diameter +135 mm length item# 42560313511 lot# 64559287.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 developed stiffness, decreased range of motion, and scar tissue/adhesions and underwent manipulation under anesthesia approximately three months and one week post implantation.At two year follow up the patient has mild pain and stiffness with normal x-ray, no revision reported.Attempts to obtain additional information have been made; however, no more information is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, b7, g3, g6, h1, h2, h3, h6, and h10 it was reported a patient had a total knee arthroplasty.Subsequently, approximately 3 months later, underwent a manipulation under anesthesia, due to stiffness.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.

• Brand Name: FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 5, 5+ 5 MM THICKNESS
• 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: 13942689
• Report Number: 0001822565-2022-00914
• Device Sequence Number: 4612209
• Product Code: JWH
• UDI-Device Identifier: 00889024556911
• UDI-Public: (01)00889024556911(17)290731(10)64468789
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 06/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42556805805
• Device Lot Number: 64468789
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White