MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE (MC) LEFT 16 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the wrong product was implanted into a patient.The patient accidentally received cementless implants intraoperatively.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).D10-medical product: cruciate retaining left size 11 pps standard femur item# 42508607001 lot# 65614548.0â° spiked keel left size g osseoti tibia item# 42535007901 lot# 66640193.All poly patella cemented 38 mm diameter item# 42540000038 lot# 66611795.Palacos rg 1x40 single item# 00111314001 lot# 68911257.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
Upon reassessment of the information, it was determined that this item was reported in error.There was no allegation against the articular surface as the allegations are only against cementless components that were implanted.Please void previous report regarding the articular surface.
Additional Manufacturer Narrative
Upon reassessment of the information, it was determined that this item was reported in error.There was no allegation against the articular surface as the allegations are only against cementless components that were implanted.Please void previous report regarding the articular surface.

• Brand Name: ARTICULAR SURFACE (MC) LEFT 16 MM HEIGHT
• 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: 19817156
• Report Number: 3007963827-2024-00287
• Device Sequence Number: 15630517
• Product Code: MBH
• UDI-Device Identifier: 00889024469426
• UDI-Public: (01)00889024469426(17)270601(10)65384729
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 12/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42512100916
• Device Lot Number: 65384729
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White