MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE BASE PLATE INSERTER; IMPACTOR

Catalog Number 00-4309-044-00

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 - 01039.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.

Manufacturer Narrative

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.

Event Description

No further information is available at this time.

• Brand Name: TM REVERSE BASE PLATE INSERTER
• Type of Device: IMPACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8395605
• MDR Text Key: 137992126
• Report Number: 0001822565-2019-01040
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-4309-044-00
• Device Lot Number: 61237485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00-434901500, BASEPLATE, LOT 64057116; 00-434901500, BASEPLATE, LOT 64057116
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR