MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ARTICULAR SURFACE; PROSTHESIS KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Birth year ¿ 1956.Medical product: van ps open intl fem-lt 60 catalog # 183124 lot # 6090250.Polished finned tib tray 63mm catalog # 141251 lot # 2017070093.Report source: (b)(6).Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2022-01558.

Event Description

It was reported patient underwent a revision procedure sixteen months post implantation due to pain and functional limitation.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: UNKNOWN ARTICULAR SURFACE
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14929499
• MDR Text Key: 295320519
• Report Number: 0001825034-2022-01559
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00880304271852
• UDI-Public: (01)00880304271852(17)220825(10)835790
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K023546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2022
• Device Model Number: N/A
• Device Catalogue Number: 183620
• Device Lot Number: 835790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 80 KG