MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CRUCIATE RETAINING LEFT SIZE 11 PPS STANDARD FEMUR; 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	Malfunction
Additional Manufacturer Narrative
(b)(4).D10-medical product articular surface (mc) left 16 mm height item# 42512100916 lot# 65384729 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
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.
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 were received; therefore, the condition of the components is unknown.Primary operative notes state no intra-operative complications.However, notes also state that the patient accidentally received cementless implants intraoperatively.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.It was reported that incorrect devices were implanted however there is no information what caused it or what the initial surgeon plan was.Root cause cannot be determined.This complaint is confirmed via operative notes.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.H6: component code: proposed component (annex g) code is: - mechanical (g04) - femur.

• Brand Name: CRUCIATE RETAINING LEFT SIZE 11 PPS STANDARD FEMUR
• Common Device Name: PROSTHESIS, 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: 19817210
• Report Number: 0001822565-2024-02446
• Device Sequence Number: 12935314
• Product Code: JWH
• UDI-Device Identifier: 00889024631373
• UDI-Public: (01)00889024631373(17)321016(10)65614548
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• 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: 42508607001
• Device Lot Number: 65614548
• 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: 12/17/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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