MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROVISIONAL STEMMED TIBIAL COMPONENT; KNEE INSTRUMENTATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number cmp-(b)(4).Concomitant medical products: provisional stemmed tibial component; p/n: 00598103701, l/n: unk.Provisional stemmed tibial component; p/n: 00598103701, l/n: unk.Provisional stemmed tibial component; p/n: 00598104701, l/n: unk.Provisional stemmed tibial component; p/n: 00598104701, l/n: unk.Provisional stemmed tibial component; p/n: 00598105701, l/n: unk.Provisional stemmed tibial component; p/n: 00598105701, l/n: unk.Provisional stemmed tibial component; p/n: 00598104702, l/n: unk.Provisional stemmed tibial component; p/n: 00598104702, l/n: unk.Provisional stemmed tibial component; p/n: 00598103702, l/n: unk.Provisional stemmed tibial component; p/n: 00598103702, l/n: unk.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00360, 0001822565 - 2020 - 00361, 0001822565 - 2020 - 00362, 0001822565 - 2020 - 00363, 0001822565 - 2020 - 00364, 0001822565 - 2020 - 00365, 0001822565 - 2020 - 00367, 0001822565 - 2020 - 00368, 0001822565 - 2020 - 00369.Product location is unknown.

Event Description

It was reported the instruments were found to be fractured.There was no patient involvement.No adverse events have been reported as a result of the malfunction.

Event Description

No further event information available at the time of this report.Consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Updated: a5, b4, b5, d4, d10, g4, g7 additional: h1, h2, h4, h10.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 updated and additional information.Updated: a5, b4, b5, g4, g7.Additional: h1, h2, h3, h6, h10.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned provisional confirmed that the returned devices are fractured.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to normal wear from use during the instrument¿s field life.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 event information available at the time of this report.

• Brand Name: PROVISIONAL STEMMED TIBIAL COMPONENT
• Type of Device: KNEE INSTRUMENTATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9639345
• MDR Text Key: 195421082
• Report Number: 0001822565-2020-00359
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• 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: 00598103701
• Device Lot Number: 62126235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1