MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE F 14 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Joint Laxity (4526)

Event Date 08/19/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial knee surgery.Subsequently one day post-op, the mcl and lcl had failed causing a lack of stability in the joint.The patient was revised the next day.The surgeon implanted a rotating hinge knee system to provide rotation stability.Attempts have been made and all available information has been provided.

Manufacturer Narrative

(b)(4).D10: 00588001602 - right size f cemented option femoral component femoral plastic cap must be removed prior to implantation - 65672131.00599003602 - prc agmt block post sz f 10mm - 64591069.00599003610 - distal femoral augment block precoat may be used with posterior and/or anterior blocks size f 5 mm augment with screw - 65539658.00588000400 - size 4 precoat cemented tibial component - 65916390.00598800426 - tibial block and screws precoat size 4 5 mm thickness - 63521431.00598801012 - 12mm diameter 100mm length straight stem extension combined length 145mm - 65813042.00598801010 - 10mm diameter 100mm length straight stem extension combined length 145mm - 65812993.66044274 - palacospro 75g - d110.66056768 - palacos r+g fast - 64731209.66044274 - palacospro 75g - d104.00588006014 - 14mm height size f articular surface with hinge post extension / use with plate 5,6 / screw enclosed do not discard - 65814281.G2 : foreign country : australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02399.

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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.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.

• Brand Name: ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE F 14 MM HEIGHT
• 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: 17914803
• MDR Text Key: 325417938
• Report Number: 0001822565-2023-02807
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024196247
• UDI-Public: (01)00889024196247(17)290405(10)65071440
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070978
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• 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: 00585006014
• Device Lot Number: 65071440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male