MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT POROUS SIZE F RIGHT; PROSTHESIS, KNEE

Model Number	5972-16-02
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial total knee arthroplasty, the size of the femoral component did not correspond to the size on the packaging.The surgeon prepared the knee for a certain size and the implant that was opened was one size too large, despite indicating it was the correct size on the package.No patient impact or adverse events have been reported as a result of the malfunction and the surgery was completed with a different implant of the correct size.Due diligence is in process for this event; to date no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: suggested component code: mechanical (g04) - femur.Visual examination of the returned product verified the product packaging and labeling matched femoral component porous size f right as well the patient labels.Measurement of the product identifier across the condyles measured size f.Additionally, the engraving on the product is f.Device history record review was not performed as the returned product was found to be conforming to specifications.The evaluation of device found that the device was labeled and measured within specification and hence no issue with the device was seen.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL COMPONENT POROUS SIZE F RIGHT
• 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: 17011045
• Report Number: 0001822565-2023-01421
• Device Sequence Number: 6872909
• Product Code: JWH
• UDI-Device Identifier: 00889024215078
• UDI-Public: (01)00889024215078(17)300531(10)64699329
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/24/2023

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: 5972-16-02
• Device Catalogue Number: 00597201602
• Device Lot Number: 64699329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2020
• 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: 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
• Patient Sex: Prefer Not To Disclose