MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED STANDARD RIGHT SIZE 7; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Bursitis (4832)
Date of Event	05/05/2021
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 & mdrs: 42542006702 tibia fixed cemented right size d lot# 64394514; mdr: 0001822565-2023-01005; 42522800514 articular surface fixed bearing constrained condylar knee rt 14mm lot# 64393666; mdr: 0001822565-2023-01006; 42560113516 stem extension straight splined uncemented 16mm dia 135mm l lot# 64759593; mdr: 0001822565-2023-01007; 42556606205 femoral distal augment cemented size 7, 7+ 5mm thickness lot# 64679953; mdr: 0001822565-2023-01008; 42556606205 femoral distal augment cemented size 7, 7+ 5mm thickness lot# 64716489; mdr: 0001822565-2023-01009; 42560313513 stem extension 3mm offset splined uncemented 13mm dia 135mm l lot# 64783425; mdr: 0001822565-2023-01010; 42555803205 tibial augment cemented half block right lateral size cd 5mm lot# 64664288; mdr: 0001822565-2023-01011; 42555803405 tibial augment cemented half block right medial size cd 5mm lot# 64661874; mdr: 0001822565-2023-01012; 42545000512 tibial central cone size medium lot# 64680479; mdr: 0001822565-2023-01013.
Event or Problem Description
Approximately nine months post knee arthroplasty revision, the patient reported mild anterior knee pain and was prescribed physical therapy.The patient¿s pain continued throughout the course of the study and two years, three months later, reported severe pain and stiffness to the right knee.No significant findings were found on radiographic imaging, no intervention has been reported, and the patient completed the study.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d2, g1, g3, g6, h1, h2, h10.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Approximately nine months post knee arthroplasty revision, the patient reported mild anterior knee pain and was prescribed physical therapy and given steroid injection for it band and per anserine bursitis.The patient¿s pain continued throughout the course of the study and two years, three months later, reported severe pain and stiffness to the right knee.No significant findings were found on radiographic imaging, and the ongoing pain is attributed to to the patient's spinal stenosis.
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.H6-component code- suggested code: mechanical 04- femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no instability, pain requiring steroid injection, stiffness, bursitis and back pain due to spinal stenosis.No x-ray complications.Complaint was confirmed by medical records.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: FEMUR CEMENTED STANDARD RIGHT SIZE 7
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16732391
• Report Number: 0001822565-2023-01004
• Device Sequence Number: 15169159
• Product Code: JWH
• UDI-Device Identifier: 00889024562561
• UDI-Public: (01)00889024562561(17)300630(10)64779935
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2023

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: 42504606202
• Device Lot Number: 64779935
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 03/29/2023; 07/07/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/25/2023; 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White