MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CRUCIATE RETAINING CEMENTED STANDARD FEMORAL COMPONENT LEFT SIZE 11; 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); Swelling/ Edema (4577)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee manipulation under anesthesia to address arthrofibrosis approximately three (3) months post-operatively.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).Concomitant devices: persona medial congruent articular surface left 10mm catalog #: 42512100810 lot #: 64945564, persona cemented stemmed tibial component left size f catalog #: 42532007501 lot #: 64830819, persona cemented all poly patella 35mm catalog #: 42540000035 lot #: 64969206.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2022-00089.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 under anesthesia is used to treat and resolve arthrofibrosis (scar tissue).This procedure is performed to increase articular motion and reduce chronic pain.As the indication for manipulation under anesthesia is related to limited range of motion and stiffness from adhesions/scar tissue, the root cause of the adverse event is related to the patient's condition, rather than the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent a knee manipulation under anesthesia to address arthrofibrosis, pain and swelling approximately three (3) months post-operatively.Initial operative notes noted no intraoperative complications.Manipulation operative notes noted a small flexion contracture and flexion to eighty (80) degrees.The procedure was completed without much force and no complications were reported.Attempts have been made, however, no additional information is available.

• Brand Name: PERSONA CRUCIATE RETAINING CEMENTED STANDARD FEMORAL COMPONENT LEFT SIZE 11
• 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: 14110833
• Report Number: 3007963827-2022-00088
• Device Sequence Number: 6428088
• Product Code: JWH
• UDI-Device Identifier: 00889024230439
• UDI-Public: (01)00889024230439(17)310111(10)64958440
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 42502607001
• Device Lot Number: 64958440
• 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: 03/22/2022
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Ethnicity: Hispanic
• Patient Race: White