MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED NARROW RT SIZE 8; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Swelling/ Edema (4577); Joint effusion (4849)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a right total knee arthroplasty.Subsequently, about 2 years two months post procedure the patient fell for unknown reasons, causing pain and swelling.Patient was seen in the office where knee was aspirated without complication.
Additional Manufacturer Narrative
(b)(4).H6-component code- suggested code: mechanical (g04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: visit #1: severe pain with twisting/pivoting, moderate stiffness; visit #2: began to have pain a few months following a fall.Cause of the fall is unknown.X-ray showed satisfactory position/alignment without evidence of lysis, wear, loosening, or gross failure.Successful aspiration of the knee performed.Complaint is confirmed with the provided medical records.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.Additional associated products & mdrs: 42532007102 tibia cemented 5 degree stemmed right size e lot# 64780562 mdr: 3007963827-2023-00125.42522600712 articular surface fixed bearing (cps) right 12mm lot# 64650133 mdr: 3007963827-2023-00126.42540000029 all poly patella cemented 29 mm diameter lot# 64843489 mdr: 0002648920-2023-00093.42557000114 stem extension tapered cemented 14mm di +30mm l lot# 64922924 mdr: 0001822565-2023-01272.

• Brand Name: FEMUR CEMENTED POSTERIOR STABILIZED NARROW RT SIZE 8
• Common Device Name: INSTRUMENT, 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: 16913357
• Report Number: 3007963827-2023-00124
• Device Sequence Number: 20471902
• Product Code: JWH
• UDI-Device Identifier: 00889024228788
• UDI-Public: (01)00889024228788(17)300531(10)64706246
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/09/2023

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: 42500006402
• Device Lot Number: 64706246
• 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: 04/19/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White