MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE F; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10-medical product: femur cemented (cr) standard left size 9 item# 42502606601 lot# 65460406.Articular surface (mc) left 10 mm height item# 42512100810 lot# 65797696.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was revised approximately one year three weeks post implantation due to pain.Attempts to obtain additional information have been made; however, no more information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No devices or photos were received; therefore, the condition of the components is unknown.X-rays provided were reviewed by third party hcp state anatomic alignment of the left knee arthroplasty without interval change through the nine-month post-operative images.Bone quality appears mildly osteopenic.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE F
• 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: 19208490
• Report Number: 3007963827-2024-00151
• Device Sequence Number: 7927125
• Product Code: MBH
• UDI-Device Identifier: 00889024471078
• UDI-Public: (01)00889024471078(17)321120(10)65546684
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: 42532007501
• Device Lot Number: 65546684
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male