MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROLONG TIBIAL INSERT SZ 3 +0; PROSTHESIS, ANKLE

Model Number 00-4500-053-00

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

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 06/27/2021

Event Type  Injury  

Event Description

Patient underwent an initial right ankle total reconstruction.Patient presented at the ed six-year post-op with right lower extremity pain and swelling around the ankle with mild radiation to right lower calf.Patient reports still taking daily pain medications.No additional complications are reported at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: ref.00450004300 lot 62622280 tibial baseplat.Ref.00450002300 lot 11014730 talar component.Unk trimmed hook plate non-zimmer fibular plate.Zimmer osteobond.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.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 -2022 -03504, 0001822565 -2022 -03505, 0001822565 -2022 -03508.Device remains implanted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, e1, e2, e3, g3, g6, h1, h2, h3, h6, h10.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.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: PROLONG TIBIAL INSERT SZ 3 +0
• Type of Device: PROSTHESIS, ANKLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16024958
• MDR Text Key: 305915894
• Report Number: 0001822565-2022-03506
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 00-4500-053-00
• Device Catalogue Number: 00450005300
• Device Lot Number: 62969943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Race: Black Or African American