MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 5, 5+ 10 MM THICKNESS; 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	03/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-00501, 0001822565-2022-00502, 0001822565-2022-00504, 0001822565-2022-00505, 0001822565-2022-00506, 0001822565-2022-00507, 0001822565-2022-00508, 0001822565-2022-00509, 0001822565-2022-00510.Concomitant medical products: femur cemented standard left size 5, item#: 42504605801, lot#: 64541282.Femoral posterior augment cemented size 5, 5+ 10 mm thickness, item#: 42556805810, lot#: 64363735.Femoral posterior augment cemented size 5, 5+ 10 mm thickness, item#: 42556805810, lot#: 64499740.Femoral posterior augment cemented size 5, 5+ 10 mm thickness, item#: 42556805810, lot#: 64499740.Stem extension 3mm offset splined uncemented 15 mm diameter +135 mm length, item#: 42560313515, lot#: 64769715.Tibia fixed cemented left size d stem extension use required, item#: 42542006701, lot#: 64334564.Articular surface fixed bearing cck) left 14 mm height, item#: 42512800414, lot#: 64316032.Stem extension 3mm offset splined uncemented 13 mm diameter +135 mm length, item#: 42560313513, lot#: 64769817.Tibial central cone size fixed tibia, item#: 42545000508, lot#: 64643004.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient experienced moderate l pes anserine bursitis approximately eight months post implantation.The patient was given cortisone injections and the issue resolved.Attempts to obtain additional information have been made; however, no more information is available.
Event or Problem Description
It was reported that a patient experienced pain and pes anserine bursitis requiring ongoing and consecutive steroid injections approximately seven months post revision surgery.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient was revised and requires post revision injections.Pes anserinus burstitis on left knee confirmed.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot 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.H6: component code: proposed component (annex g) code is mechanical (g04) - femur.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, b7, d2, g1, g3, g6, h1, h2, and h11.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, and h11.Corrected: h4, h6 component code.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient was revised and requires post revision injections.Pes anserinus bursitis on left knee confirmed.The patient has been treated with cortisol injections for pain.The patients presented mild-pain and was put on pain management for peripheral neuropathy although not related to the study knee.X-rays presented no significant findings.The patient was treated approximately one year ago for a left knee per bursitis with cortisone injection.A definitive root cause cannot be determined.This complaint is confirmed based on the medical records provided.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue.To monitor for trends.

• Brand Name: FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 5, 5+ 10 MM THICKNESS
• 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 ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13548328
• Report Number: 0001822565-2022-00503
• Device Sequence Number: 14766639
• Product Code: JWH
• UDI-Device Identifier: 00889024556980
• UDI-Public: (01)00889024556980(17)290331(10)64363735
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/21/2025

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: 42556805810
• Device Lot Number: 64363735
• 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: 02/11/2022; 05/16/2022; 08/27/2024; 03/17/2025
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/08/2022; 05/20/2022; 09/24/2024; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White