MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE 15 MM POST LENGTH UNCEMENTED; PROSTHESIS, EXTREMITY

Catalog Number 00434901500

Device Problem Failure to Disconnect (2541)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdrs were filed in association with this event.Please also reference: 0001822565 - 2019 - 01040.Primary udi# (b)(4).Report source: foreign.The event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the impactor could not be disengaged from the baseplate during implantation.No further information is available at this time.

Event Description

No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Examination of the returned complaint product does not confirm the reported inability to disassemble the devices.A functional check was performed and the inserter disengaged as intended.Review of device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event.Root cause was unable to 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 15 MM POST LENGTH UNCEMENTED
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8395638
• MDR Text Key: 137993506
• Report Number: 0001822565-2019-01039
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00434901500
• Device Lot Number: 64057116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00-4309-044-00, INSERTER, 61237485; 00-4309-044-00, INSERTER, 61237485
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR