MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING PS LEFT 11 MM HEIGHT; PROSTHESIS, KNEE

Model Number	42-5124-007-11
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: femur cemented posterior stabilized (ps) standard left size 8: catalog#42500606401, lot#65040479; all poly patella cemented 35 mm diameter: catalog#42540000035, lot#65134460; natural tibia cemented 5 degree stemmed left size e: catalog#42532007101, lot#65046608; unknown cement: catalog#ni, lot#ni.Multiple mdr reports have been filed for this event.Please see associated reports: 3007963827-2022-00020; 0002648920-2022-00011.Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product 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 via a clinical study that a patient underwent an initial left total knee arthroplasty.Approximately two months post implantation, the patient presented with symptoms including pain, stiffness, and limited range of motion.The patient then underwent a manipulation under anesthesia without complication.At the initial post operative visit, the patient exhibited increased range of motion and slow release of adhesions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Device history record review was not performed as the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.Patient had a manipulation under anesthesia due to pain, stiffness, and limited range of motion after initial left total knee arthroplasty.Manipulation of a joint is a mobilization manipulation under anesthesia and 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: ARTICULAR SURFACE FIXED BEARING PS LEFT 11 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: 13307615
• Report Number: 3007963827-2022-00021
• Device Sequence Number: 12003223
• Product Code: MBH
• UDI-Device Identifier: 00889024237254
• UDI-Public: (01)00889024237254(17)260315(10)64981135
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• 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
• Report Date (Section B): 05/05/2022

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 Expiration Date: 03/15/2026
• Device Model Number: 42-5124-007-11
• Device Catalogue Number: 42512400711
• Device Lot Number: 64981135
• 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: 12/28/2021
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White