MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED STANDARD CEMENTED FEMORAL COMPONENT RIGHT SIZE 6; 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); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Numbness (2415)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - persona posterior stabilized articular surface right 10mm catalog #: 42522600510 lot #: 64782011, persona cemented stemmed tibial component right size d catalog #: 42532006702 lot #: 64950550, persona cemented all-poly patella 29mm catalog #: 42540200029 lot #: 65029438.The complainant has indicated that the product will not be returned to zimmer biomet for investigation as the devices remain implanted.According to tabers medical dictionary, manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint, with or without anesthesia.Per clinical orthopaedics and related research, manipulation is used to treat and resolve arthrofibrosis, or scar tissue.This procedure is performed to increase articular motion and reduce chronic pain from arthrofibrosis.As the indication for manipulation is related to limited range of motion and stiffness due to adehesions/scar tissue, the root cause is traced to non-device related factors.Multiple mdr report was filed for this patient; please see all reports associated with this event: 3007963827-2022-00164.
Event or Problem Description
It was reported that the patient underwent a right knee manipulation under anesthesia to address pain, swelling and stiffness six (6) weeks following right knee arthroplasty.Initial operative notes noted no intraoperative complications and the patient was taken to recovery in stable condition.The patient's post-operative range of motion was zero (0) to one hundred thirty (130) degrees.Outpatient therapy was instructed for range of motion and pain management.Manipulation operative notes noted the patient underwent a manipulation under anesthesia with a corticosteroid injection to address right knee stiffness.Utilizing gentle pressure, knee flexion was increased with audible lysis of adhesions.The patient was transferred to recovery in stable condition.No additional patient consequences were reported.

• Brand Name: PERSONA POSTERIOR STABILIZED STANDARD CEMENTED FEMORAL COMPONENT RIGHT SIZE 6
• 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: 14652845
• Report Number: 3007963827-2022-00163
• Device Sequence Number: 11988167
• Product Code: JWH
• UDI-Device Identifier: 00889024229204
• UDI-Public: (01)00889024229204(17)300811(10)64766271
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42500606002
• Device Lot Number: 64766271
• 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: 05/24/2022
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White