MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE CD; INSTRUMENT, KNEE

Catalog Number 42517000303

Device Problems Fracture (1260); Difficult to Insert (1316)

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

Event Date 11/15/2023

Event Type  malfunction  

Event Description

It was reported that during an initial total knee procedure, the tibial articular surface provisional instrument was chipped and unable to be inserted during the trialing process.There was no patient impact and no adverse events have been reported as a result of the malfunction.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).D10: medical product: mc tibial articular surface provisional left size 4-5 cd top: catalog#42517100310, lot#ni.Multiple mdr reports have been filed for this report; please see associated report: 0001822565-2023-03419.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.

Event Description

No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: suggested component code: mechanical (g04) - provisional bottom.The reported event was confirmed via provided photographs.Visual examination of the pictures identified the unit as chipped.A review of the device history records could not be performed as lot number was not provided.A definitive root cause could not 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d1; d2; d4; d9; d10; g3; g4; h2; h3; h4; h6; h10.D10: medical product: mc tibial articular surface provisional left size 4-5 cd top: catalog#42517100310, lot#65120752 the product has been received by zimmer biomet and prompted a review of the previously reported investigation results.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

No further event information at time of this report.

• Brand Name: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE CD
• Type of Device: INSTRUMENT, 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: 18256014
• MDR Text Key: 329600176
• Report Number: 0001822565-2023-03418
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024238459
• UDI-Public: (01)00889024238459(10)65158058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42517000303
• Device Lot Number: 65158058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose