MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per a report from the legal department the patient underwent a left knee replacement (b)(6) 2017.Approximately 1 year and 4 months after the initial procedure the patient had a left knee revision on (b)(6) 2019 due to pain, discomfort and instability.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H6.Investigation - based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Event or Problem Description
As reported via the legal department the patient underwent a left knee replacement (b)(6) 2009.Approximately 8 years and 9 months after the initial procedure the patient had a left knee revision on (b)(6) 2017 due to pain, discomfort and instability.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2017.Diagnosis: left painful total knee replacement there was a significant amount of synovial fluid.It was noted significant poly wear in the medial compartment.The patient tolerated procedure well and went to the pacu in stable condition.
Additional Manufacturer Narrative
D10.Concomitants: cat#200-02-32; three peg patella, sn (b)(6); cat#204-04-22; trapezoid tibial tray sz, sn (b)(6); cat#234-02-02; optetrak asy,ps cemented, sn (b)(6).Initial information was provided in the legal filing.These devices are used for treatment not diagnosis.Pending new investigation.There is no other information provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS TIBIAL INSERTS SZ 2, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16806428
• Report Number: 1038671-2023-00815
• Device Sequence Number: 1942824
• Product Code: JWH
• UDI-Device Identifier: 10885862048233
• UDI-Public: 10885862048233
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/17/2024

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 Expiration Date: 11/04/2016
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 204-22-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 06/29/2023; 12/16/2024
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 04/26/2023; 09/26/2023; 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2008
• 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: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female