MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT THN 31 3 PEG; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Scar Tissue (2060); Swelling (2091); Alteration In Body Temperature (2682)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-10921, 0001825034-2018-10922, 0001825034-2019-03497.Event date: unknown date in (b)(6) 2018.(b)(4).Concomitant medical products: vanguard ps femoral, catalog #: 183104, lot #: j3642784.Biomet cc cruciate tray, catalog #: 141233, lot #: j6035794.Vanguard ps tibial bearing, catalog #: 183642, lot #: 081060.Palacos rg, catalog #: 00111314001, lot #: 86004593.Concomitant medical products: therapy date: unknown date in (b)(6) 2018.Reported event was unable to be confirmed due to limited information from the customer.Primary operative notes provided state that there were no intra-operative complications.No devices or photos were received; therefore, the condition of the components is unknown.Device history record (dhr) was reviewed for deviations and/ or anomalies with no relevant deviations / anomalies identified.Root cause cannot be determined with the information 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

It was reported that patient underwent underwent a procedure to remove scar tissue and experienced inflammation, swelling, and warm to the touch.Patient alleges possible metal allergy and will undergo further testing.

• Brand Name: SERIES A PAT THN 31 3 PEG
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8875101
• MDR Text Key: 153712571
• Report Number: 0001825034-2019-03498
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: N/A
• Device Catalogue Number: 184784
• Device Lot Number: 503700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 80