MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Failure of Implant (1924)

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item#: 42530008301; natural tibia trabecular metal two-peg porous fixed bearing left size h; lot#: 64678651.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the sales rep stated it is not able to be sent back.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during an initial tka, the poly wouldn't lock in.Surgeon made sure to check it was cleared out and it wouldn't lock.A new poly was opened and used.

Event Description

No further event information is 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.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 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
• MDR Report Key: 12146799
• MDR Text Key: 260953300
• Report Number: 3007963827-2021-00144
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024235977
• UDI-Public: (01)00889024235977(17)240531(10)64221696
• Combination Product (y/n): N
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• 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: 42512100911
• Device Lot Number: 64221696
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1