MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING (CR) LEFT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 foreign source: singapore.Product has been received by zimmer biomet and 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 during a knee procedure, the surgeon seated the tibial insert on the tibial tray but noted there was soft tissue between the devices.The surgeon extracted the tibial insert from the tray and removed the soft tissue.The surgeon seated the insert again but it would easily be removed with an extractor.The surgeon attempted a third time but the same issue persisted.The procedure was completed using a different tibial insert.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6.Visual examination of the returned product/ provided pictures shows that the dovetail feature is flared.The device history record was reviewed and no discrepancies relevant to the reported event were found.Detailed instructions for inserting the articular surface are provided in the persona personalized alignment total knee arthroplasty surgical technique and there is a note to 'insert an articular surface only once.Never reinsert the same articular surface onto a tibial baseplate' and that when trialing the surgeon should 'ensure that the trials are fully seated appropriately.Soft tissue can get trapped under the femur, causing inadvertent placement of femoral trial in flexion.At the time of insertion of the articular surface the area should then be clear of tissue.The root cause is attributed to use error.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: ARTICULAR SURFACE FIXED BEARING (CR) LEFT 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17613719
• Report Number: 3007963827-2023-00222
• Device Sequence Number: 6745999
• Product Code: JWH
• UDI-Device Identifier: 00889024235045
• UDI-Public: (01)00889024235045(17)280125(10)65633826
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K172524
• 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): 12/29/2023

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: N/A
• Device Catalogue Number: 42512000410
• Device Lot Number: 65633826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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: Unknown