MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE RIGHT 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: persona cruciate retaining standard porous femoral component catalog #: 42502806202 lot #: 64806946, persona natural two-peg porous fixed bearing tibial component right size f catalog #: 42530007502, lot #: 64872083.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.Manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint, with or without anesthesia.Per clinical orthropaedics and related research (how to treat the stiff total knee arthroplasty? a systematic review), manipulation under anesthesia (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.Based on the records provided, the root cause is attributed to non-device related factors.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2021-00223, 0001822565-2021-02804.
Event or Problem Description
It was reported that the patient underwent a right knee manipulation under anesthesia to address post-operative pain and stiffness approximately four (4) months post-operatively.Initial operative notes did not identify any intraoperative complications.At the patient's 3-month post-operative visit, the patient was struggling with anterior knee discomfort, clicking sounds in the knee and limited range of motion.Manipulation operative notes noted release of adhesions without any intraoperative complications.

• Brand Name: PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE RIGHT 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
• MDR Report Key: 12556246
• Report Number: 3007963827-2021-00223
• Device Sequence Number: 4584258
• Product Code: MBH
• UDI-Device Identifier: 00889024468351
• UDI-Public: (01)00889024468351(17)250630(10)64688789
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 42522100712
• Device Lot Number: 64688789
• 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: 09/15/2021
• Initial Report FDA Received Date: 09/30/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 93