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

Model Number N/A

Device Problems Difficult to Insert (1316); Dent in Material (2526)

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

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign - (b)(6).The 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.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2023-00299.

Event Description

It was reported that during a knee arthroplasty, the mating slot on the front of the tibial baseplate broke while engaging the articular surface via persona articular surface inserter.The articular surface failed to engage in an optimal position.It was stuck and surgeon struggled to remove it out, resulting in a dent and scratch on the articular surface.Therefore, a new articular surface was opened as per request.The broken tibial baseplate component was already cemented into the tibia so it remained implanted.The surgical delay was approximately 20 minutes to remove the stuck articular surface and to put in a new one.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned articular surface lot#: 65739545 exhibits signs of use (flared dovetail) and damage as alleged.Tibial implant was not returned and no photos provided to confirm fracture.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined for the mating issue or the broken tibial plate.However, leaving a broken/damaged tibial plate in the patient is considered use error as the ifu states 'do not use any component if damage is found or caused during setup or insertion.' this complaint has been confirmed for the mating issue via the flared articular surface but the tibial plate fracturing could not be confirmed.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: ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 10 MM HEIGHT
• Type of Device: 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: 18048825
• MDR Text Key: 327086405
• Report Number: 3007963827-2023-00300
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024243750
• UDI-Public: (01)00889024243750(17)280331(10)65739545
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K121771
• 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
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42522400710
• Device Lot Number: 65739545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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