MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION STRAIGHT SPLINED UNCEMENTED 20 MM DIA 35 MM L; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient was experiencing mild swelling, stiffness and pes anserine tenderness approximately 3 months post implantation.Mild bloody drainage and periincisional drainage was also noted.Patient was treated with voltaren topical gel and physical therapy.Attempts to obtain additional information have been made; however, no more is available at this time.Is available at this time.
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 & mdrs: 42556606605 femoral distal augment cemented size 9, 9+ 5 mm lot# 64336296 mdr: 0001822565-2022-00521; 42556606605 femoral distal augment cemented size 9, 9+ 5 mm lot# 64336296 mdr: 0001822565-2022-00522; 42504606611 femur cemented plus left size 9+ lot# 64607971 mdr: 0001822565-2022-00524; 42555807305 tibial augment cemented half block left medial size gh 5mm lot# 64610715 mdr: 0001822565-2022-00525; 42555807105 tibial augment cemented half block left lateral size gh 5 mm lot# 64499790 mdr: 0001822565-2022-00526; 42545000512 tibial central cone size medium lot# 64500865 tmt mdr: 0001822565-2022-00527; 42560113516 stem extension straight splined uncemented 16 mm dia 135 mm l lot# 64638317 mdr: 0001822565-2022-00528; 42512800914 articular surface fixed bearing constrained condylar knee(cck) left 14mm lot# 64264925 mdr: 0001822565-2022-00529; 42542007901 tibia fixed cemented left size g lot# 64296014 mdr: 0001822565-2022-00530.
Additional Manufacturer Narrative
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.Not reportable as ae is for mild tenderness of the pes aneserinus and prescribed topical cream, patient tolerated.No allegations against zb product.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: STEM EXTENSION STRAIGHT SPLINED UNCEMENTED 20 MM DIA 35 MM L
• Common Device Name: 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 ; .; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13576737
• Report Number: 0001822565-2022-00523
• Device Sequence Number: 17596681
• Product Code: JWH
• UDI-Device Identifier: 00887868249853
• UDI-Public: (01)00887868249853(17)290930(10)64542462
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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 Model Number: N/A
• Device Catalogue Number: 42560113520
• Device Lot Number: 64542462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 109 KG