MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED STANDARD LEFT SIZE 11; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Fibrosis (3167)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2022-00039, 0001822565-2022-00543, 0001822565-2022-00544, 0001822565-2022-00545, and 0001822565-2022-00546.Medical devices: all poly patella cemented 35 mm diameter: catalog#: 42540000035, lot#: 64775286; stem extension tapered cemented 14 mm diameter +75 mm length: catalog#: 42560007514, lot#: 64777413; tibia fixed cemented left size g: catalog#: 42542007901, lot#: 64573173; articular surface fixed bearing constrained condylar knee (cck) left 10 mm height: catalog#: 42512801010, lot#: 64298185; stem extension tapered cemented 14 mm diameter +75 mm length: catalog#: 42560007514, lot#: 64769921.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 patient had left knee pain and crepitation consistent with arthrofibrosis approximately sixteen months post-implantation.The patient was scheduled for an arthroscopy and debridement but it is unknown if it has occurred.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2022-00039, 0001822565-2022-00543, 0001822565-2022-00544, 0001822565-2022-00545, and 0001822565-2022-00546.Medical devices: all poly patella cemented 35 mm diameter: catalog#: 42540000035, lot#: 64775286; stem extension tapered cemented 14 mm diameter +75 mm length: catalog#: 42560007514, lot#: 64777413; tibia fixed cemented left size g: catalog#: 42542007901, lot#: 64573173; articular surface fixed bearing constrained condylar knee (cck) left 10 mm height: catalog#: 42512801010, lot#: 64298185; stem extension tapered cemented 14 mm diameter +75 mm length: catalog#: 42560007514, lot#: 64769921.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 patient had left knee pain and crepitation consistent with arthrofibrosis approximately sixteen months post-implantation.The patient was scheduled for an arthroscopy and debridement but it is unknown if it has occurred.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that patient had left knee pain and crepitation consistent with arthrofibrosis approximately sixteen months post-implantation.The patient underwent an arthroscopy and debridement and no further issues have been reported.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h10.It was reported a patient had a total knee arthroplasty.Subsequently, approximately 16 months later, underwent an arthroscopy and debridement due to pain and crepitation, consistent with arthrofibrosis.An arthroscopy with debridement is used to treat and resolve arthrofibrosis (scar tissue).This procedure is performed to reduce chronic pain from arthrofibrosis.There are no allegations of device failure or surgical complications and the device remains implanted without complications.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMUR CEMENTED STANDARD LEFT SIZE 11
• 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: 13567574
• Report Number: 0001822565-2022-00542
• Device Sequence Number: 10920753
• Product Code: JWH
• UDI-Device Identifier: 00889024562592
• UDI-Public: (01)00889024562592(17)300531(10)64655857
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42504607001
• Device Lot Number: 64655857
• 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: 02/23/2022; 06/02/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 03/23/2022; 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2020
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 86 KG