MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CONSTRAINED POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee manipulation under anesthesia to address arthrofibrosis approximately three (3) months following left knee arthroplasty.Initial operative notes noted no intraoperative complications.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices - persona posterior stabilized cemented narrow femoral component left size 8 catalog #: 42500006401 lot #: 64068776, persona cemented stemmed tibial component left size d catalog #: 42532006701 lot #: 64072823, persona cemented stem extension 14mm catalog #: 42557000114 lot #: 64229084, persona cemented all poly patella 32mm catalog #: 42540000032 lot #: 64208861, unknown palacos bone cement catalog #: ni lot #: ni.The complainant indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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.Based on the information provided, the root cause of the reported event is determined to be unrelated to the implanted devices.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2023-00077.Reported event is not related to device.

• Brand Name: PERSONA CONSTRAINED POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 12MM
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16686625
• Report Number: 3007963827-2023-00076
• Device Sequence Number: 6111574
• Product Code: MBH
• UDI-Device Identifier: 00889024237933
• UDI-Public: (01)00889024237933(17)230430(10)63996687
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42512600512
• Device Lot Number: 63996687
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• 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: Female
• Patient Weight: 110 KG