MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PLUS FEMORAL PROVISIONAL; INSTRUMENT KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: hex headed screw catalog # 00590103548, lot # 65751311.Hex headed screw catalog # 00590103527, lot # 65665459.Headless trocar drill pin catalog # 00590102000, lot # 65551257.Stem extension catalog # 42560317515, lot # 64973667.Femoral posterior augment cemented catalog # 42556806205, lot # 65042368.All-poly patella cemented catalog # 42540200035, lot # 65594018.Femoral central cone catalog # 42545001011, lot # 64751267.Femoral posterior augment cemented catalog # 42556806210, lot # 64953962.Femoral distal augment cemented catalog # 42556606205, lot # 64963209.Femoral distal augment cemented catalog # 42556606210, lot # 65263606.Tibia fixed cemented stem extension use required catalog # 42542007101, lot # 65597102.Articular surface fixed bearing constrained posterior stabilized (cps) catalog # 42512600710, lot # 65197005.Stem extension 6mm offset splined uncemented catalog # 42560613517, lot # 64948001.Tibial central cone catalog # 42545000510, lot # 64643011.Report source: australia.Customer has indicated that the product will not be returned because it remains implanted.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 patient had fractured femur upon final trailing post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Correction: d1, d2, d4, d10, g4, h5, h8.D10 - medical product: femur cemented catalog # 42504606211 lot # unknown.H6: suggested component code: mechanical (g04) - femur.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.X-ray review indicates there is total left knee arthroplasty with four cerclage wires along the femoral component, surgical staples, osteopenia, air and fluid around soft tissues consistent with recent surgery, no bony fracture seen.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.

• Brand Name: PLUS FEMORAL PROVISIONAL
• Common Device Name: INSTRUMENT KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16860291
• Report Number: 0001822565-2023-01176
• Device Sequence Number: 5385942
• Product Code: OIY
• UDI-Device Identifier: 00889024562691
• UDI-Public: (01)00889024562691(17)310310(10)64998802
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: 42584606211
• Device Lot Number: 64998802
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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