MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALL POLY PATELLA CEMENTED 29 MM DIAMETER; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/19/2020
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 remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs: 00596403014 articular surface size cd 14 mm ht lot# 64015825 mdr: 0001822565-2021-01964.42500805802 femur trabecular metal posterior stabilized standard porous lot# 63930585 mdr: 000182256-2021-01966.00595403701 tibial tray fixed bearing size 3 lot# 63885627 mdr: 0001822565-2021-01967.
Event or Problem Description
It was reported a clinical study patient underwent primary right knee.Subsequently patient developed an effusion of right knee, and aspiration and ultrasound performed about 2 years post procedure and 30cc of fluid removed.It is noted that the reported event resolved without further incident, and patient has completed clinical study and remains implanted.
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).

• Brand Name: ALL POLY PATELLA CEMENTED 29 MM DIAMETER
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12192540
• Report Number: 0001822565-2021-01968
• Device Sequence Number: 4742761
• Product Code: JWH
• UDI-Device Identifier: 00889024247628
• UDI-Public: (01)00889024247628(17)260531(10)64063565
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 42540000029
• Device Lot Number: 64063565
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 62