MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL FEMUR CEMENTED; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: partial tibial cemented catalog # 42538000701, lot # 65036968.Biomet bc r 1x40 us catalog # 110035368, lot # zz44bj2604.Partial articular surface left medial size g 9 mm thickness catalog # 42518200709 lot # 64660677.Component code - mechanical, femur.Multiple mdr reports were filled for this event: 0001825034-2023-00871.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Medical records review indicates the following mri impression states artifact limiting study with small knee effusion.No loosening can be confirmed based on this mri report.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 patient is experiencing pain and bone scan displayed implant loosening approximately one year post implantation.No revision is planned at this time.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: PARTIAL FEMUR CEMENTED
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16775859
• Report Number: 0001825034-2023-00869
• Device Sequence Number: 6858794
• Product Code: HSX
• UDI-Device Identifier: 00880304808478
• UDI-Public: (01)00880304808478(17)300430(10)64646347
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000401
• Device Lot Number: 64646347
• 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: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• 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: Other
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White