MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE C; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problems Pain (1994); No Information (3190)

Event Date 12/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Explant date: unknown day in (b)(6) 2019.Report source: (b)(6).Customer has not indicated whether or not the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient was revised due to subsidence.There is no additional information at this time.

Manufacturer Narrative

This report is being submitted to update the event date and explant date.Updated: b3, b4, b5, d7, g4, g7, h1, h2, and h10.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

Event Description

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

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE C
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9591710
• MDR Text Key: 175066918
• Report Number: 0001822565-2020-00178
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2020

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 Model Number: N/A
• Device Catalogue Number: 42532006401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/24/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 02/20/2020; 03/30/2020
• Supplement Dates FDA Received: 02/28/2020; 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention