MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED NARROW CEMENTED FEMORAL COMPONENT LEFT SIZE 8; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: concomittant devices - persona all poly patella: cemented 32mm catalog #: 42540000032 lot #: 64208861, persona posterior stabilized articular surface left 12mm catalog #: 42512600512 lot #: 63996687, persona cemented stemmed tibial component left size d catalog #: 42532006701 lot #: 64072823, persona tapered cemented stem extension 14mm catalog #: 42557000114 lot #: 64229084, unknown.Palacos bone cement catalog #: ni lot #: ni.The synovial membrane (synovium) encloses each joint and secretes fluid to allow joints to move freely.When the synovium is irritated by debris or pathogens, it over-secrets fluid causing local pain/tenderness, inflammation, swelling, and warmth, often resulting in mobility difficulties.Synovitis is treated with steroid injections to reduce the pain and inflammation or by arthroscopic or open synovectomy.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 zimmer biomet devices.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0002648920-2023-00071, 3007963827-2023-00081, 3007963827-2023-00082 ,0001822565-2023-00956.
Event or Problem Description
It was reported that the patient underwent a left knee arthroscopy approximately seven (7) months post-operatively to address patellar clunk and a catching feeling.During the arthroscopy, synovitis and fibrous tissue at the superior pole of the patella were identified and appeared to be engaging with the box of the femur and was scarred through the medial gutter.A synovectomy was performed, and scar tissue was removed without complication.Initial operative notes noted no intraoperative complications.No additional patient consequences were reported.

• Brand Name: PERSONA POSTERIOR STABILIZED NARROW CEMENTED FEMORAL COMPONENT LEFT SIZE 8
• 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: 16714420
• Report Number: 3007963827-2023-00080
• Device Sequence Number: 12572034
• Product Code: JWH
• UDI-Device Identifier: 00889024228771
• UDI-Public: (01)00889024228771(17)280831(10)64068776
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2023

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 Model Number: N/A
• Device Catalogue Number: 42500006401
• Device Lot Number: 64068776
• 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: 03/23/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2018
• 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