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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/12/2023

Event Type  Injury  

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 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 Description

No further event information available at the time of this report.

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
• Type of Device: 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
• MDR Text Key: 314459832
• Report Number: 0001822565-2023-01176
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00889024562691
• UDI-Public: (01)00889024562691(17)310310(10)64998802
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K191625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male