MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT STD 34 3 PEG; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Burning Sensation (2146); Tingling (2171); Limited Mobility Of The Implanted Joint (2671)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed by review of medical records.Patient follow up appointment notes confirm patient was suffering from pain, stiffness, swelling, limited rom, and difficult ambulating, as well as audible noise and clicking.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.Concomitant products: 141264, tibial tray, lot # 880200.Cp113620, femur, lot # 270510.Ep-189081, tibial bearing, lot # 381110.141316, biomet finned pri stem 80x10mm, lot # 286310.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04373, 0001825034 - 2019 - 04375, 0001825034 - 2019 - 04377, 0001825034 - 2019 - 04378.
Event or Problem Description
It was reported that approximately 6 months post implantation of a right tka, the patient was suffering from weakness, stiffness, gait deviation, and pain.The patient was also further experiencing paresthesia, burning, pins and needles sensation, and instability in the affected leg.It is unknown if the patient has had any intervention.Attempts have been made and no further information has been provided.

• Brand Name: SERIES A PAT STD 34 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9139201
• Report Number: 0001825034-2019-04379
• Device Sequence Number: 3046921
• Product Code: JWH
• UDI-Device Identifier: 00880304434349
• UDI-Public: (01)00880304434349
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2023
• Device Model Number: N/A
• Device Catalogue Number: 184766
• Device Lot Number: 594120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 84