MAUDE Adverse Event Report: ZIMMER TMT NEXGEN® COMPLETE KNEE SOLUTION, TRABECULAR METAL¿¢ STANDARD PRIMARY PATELLA; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 42502806002, femur, lot # 64278763, 42530006702, tibia, lot # 64102955, 42522100412, articular surface, lot # 63811402.
Event or Problem Description
It was reported that approximately 2 months post implantation, the patient was experiencing stiffness and consequently underwent a manipulation under anesthesia with injection of the right knee.Approximately 2 weeks post manipulation, the patient's swelling had reportedly resolved.Attempts have been made and no further information has been provided.
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.No product was returned review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: - (b)(6) 2019 ¿ patient is compliant with pt, pain well controlled with meds, flexion nearly 70 & nearly full extension.Some issues with postop nausea, and rt calf swelling ¿ ultrasound ruled out dvt, incision wnl.- (b)(6) 2019 ¿ full weight bearing with antalgic (painful) gait, posterior knee pain- continues nsaids and prescription narcotics, flexion 95/ full extension, laxity and alignment normal.At 12 month visit- range of motion:active flexion 95/ extension 0; passive flexion 95/ extension 0.Degree of joint pain on average rated 9 with 10 being worst possible.Dissatisfied to very dissatisfied with pain level & joint function.Extreme stiffness noted, date of onset (b)(6) 2019.- (b)(6) 2019 ¿ after aggressive pt to gain flexion: flexion 95/ full extension, painful.Diagnosis: arthrofibrosis right knee s/p total joint replacement, recommend mua.- date of intervention (b)(6) 2020.Right knee mua & injection of right knee with marcaine & depomedrol.A definitive root cause cannot 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.

• Brand Name: NEXGEN® COMPLETE KNEE SOLUTION, TRABECULAR METAL¿¢ STANDARD PRIMARY PATELLA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9693534
• Report Number: 3005751028-2020-00011
• Device Sequence Number: 2422898
• Product Code: MBH
• UDI-Device Identifier: 00889024309814
• UDI-Public: (01)00889024309814
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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 Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00587806535
• Device Lot Number: 64245270
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 55