MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE REAMER 1; ORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT

Catalog Number 00430904100

Device Problem Degraded (1153)

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

It was reported that the baseplate reamers are dull and unusable.These were identified outside of surgery.No additional information is available at this time.

Manufacturer Narrative

(b)(4).The device has been returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 00346, 0001822565 - 2022 - 00345, 0001822565 - 2022 - 00347.

Manufacturer Narrative

(b)(4).The device has been returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 00346, 0001822565 - 2022 - 00345, 0001822565 - 2022 - 00347.

Event Description

It was reported that the baseplate reamers are dull and unusable.These were identified outside of surgery.No additional information is available at this time.

Event Description

No additional information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified lots 62364024, 63495268 , 64124856 , 64124856.All devices exhibit signs of use (nicked or gouged) and all the blades are dull.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: BASE PLATE REAMER 1
• Type of Device: ORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13474754
• MDR Text Key: 285319936
• Report Number: 0001822565-2022-00116
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00889024267527
• UDI-Public: (01)00889024267527(11)04152013(10)62364024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052906
• 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
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00430904100
• Device Lot Number: 62364024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1