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

Model Number 5972-16-02

Device Problem Wrong Label (4073)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  malfunction  

Event 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.

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.

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 Description

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

• Brand Name: FEMORAL COMPONENT POROUS SIZE F RIGHT
• Type of Device: 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
• MDR Text Key: 316048319
• Report Number: 0001822565-2023-01421
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024215078
• UDI-Public: (01)00889024215078(17)300531(10)64699329
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K173057
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose