MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLYETHYLENE INSERT XT SIZE B; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a left knee revision approximately one month post implantation due to instability.During the revision, it was noted that the femoral had fractured.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03284, 0001822565-2023-03285, and 0001822565-2023-03286.D10 medical devices: distal femoral xt component size b left catalog#: 00585004201; lot#: 65322758; femoral hinge service kit xt size b catalog#: 00585007112; lot#: 65221250.G2 foreign source: south africa.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10 medical devices: distal femoral xt component size b left; catalog#: 00585004201 lot#: 65322758.Femoral hinge service kit xt size b; catalog#: 00585007112 lot#: 65221250.Articular surface with segmental hinge post size b 14 mm height; catalog#: 00585002014 lot#: 66012050.Cerclage cable with crimp 1.8 mm dia.Cable 22 in.(559 mm) length; catalog#: 00223200118 lot#: 65355726.Optip 80 refob plus bone cmt-3; catalog#: 4722502117-3 lot#: ax30bd1106.Optip 80 refob plus bone cmt-3; catalog#: 4722502117-3 lot#: ax30bd1106.Segment with male/female taper 30 mm length; catalog#: 00585004603 lot#: 65492481.Stem collar 25 mm o.D.; catalog#: 00585204025 lot#: 64635296.Proximal tibial component (tibial body x1 tibial bushing x1) size 1; catalog#: 00585000110 lot#: 64953863.Fluted stem extension straight 13 mm diameter 130 mm stem length; catalog#: 00585205013 lot#: 65722452.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned femoral found it to exhibit signs of being implanted and the tabs are fractured off.Medical records and radiographs were provided and reviewed by a health care professional.X-ray reports dictate findings of prosthesis in position without loosening or evidence of complications.A leg length discrepancy was identified.Device history record was reviewed and no discrepancies were found.Review of complaint history found no additional related issues for this item and the reported part and lot combinations.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: POLYETHYLENE INSERT XT SIZE B
• 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: 18169997
• Report Number: 0001822565-2023-03285
• Device Sequence Number: 7716661
• Product Code: KRO
• UDI-Device Identifier: 00889024633889
• UDI-Public: (01)00889024633889(17)280325(10)65858288
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585001296
• Device Lot Number: 65858288
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 04/26/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/12/2024; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 82 KG