MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT STD 37 3 PEG; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Edema (1820); Hematoma (1884); Pain (1994); Swelling (2091); Thrombosis (2100); Numbness (2415)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: ep-189102, bearing, lot # 976390, 141205, tibial locking bar, lot # 597530, 141215, tibial tray, lot # 467350, 141314, femoral stem, lot # 845380, 183032, femoral component, lot # j6073232.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01396, 0001825034 - 2020 - 00130, 0001825034 - 2020 - 00131, 0001825034 - 2020 - 00132, 0001825034 - 2020 - 00134.
Event or Problem Description
It has been reported that approximately 5 months post l knee implantation, the patient began to experience pain to his left extremity and was found to have a dvt.The patient continued to suffer from further dvts and pe, and eventually developed a hematoma related to blood thinner treatment from the dvts.Patient has continued to have these issues, approximately 2.5 years post implantation.Attempts for additional information have been made and none has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were update/corrected updated: b4, b5, g4, g7, h2, h3, h6.Reported event was confirmed by review of medical records.Office visit notes were reviewed and stated that the patient experienced two dvts within 30 days of an i&d procedure that occurred post implantation, with ongoing hematoma and pulmonary embolism issues.It was also confirmed that the patient had suffered nerve damage due to the hematoma.Device history record (dhr) was reviewed and no discrepancies were found.The root cause for the reported issues are related to the procedure and are not abnormal to the procedure.No failure detected with the devices.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: SERIES A PAT STD 37 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9563400
• Report Number: 0001825034-2020-00133
• Device Sequence Number: 2902229
• Product Code: JWH
• UDI-Device Identifier: 00880304436633
• UDI-Public: (01)00880304436633
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K040770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: N/A
• Device Catalogue Number: 184768
• Device Lot Number: 683570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 125