MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 4, 18MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal team, patient original surgery was performed by dr.(b)(6) at (b)(6) hospital in (b)(6) in 2014.Patient moved from (b)(6) to (b)(6) after the primary surgery.Patient has had two (2) revisions in (b)(6) at (b)(6) medical center with a dr.(b)(6) says had pain and issues following the primary surgery.When patient had first revision in 2017, the surgeon corrected a ¿patellar issue¿ (the patellar button was loose he thought), and ¿tightened the knee¿.However, only the insert was exchanged.The patient continuing pain and mobility issues, then in (b)(6) 2021 had a second revision.Patient believes all the components were removed in 2021, and surgeon said he had significant lysis.Patient has had to work from home since the surgery, has leg length issues, continuing pain, etc.Patient is male, (b)(6) and has very limited mobility.
Additional Manufacturer Narrative
Concomitant products: trapezoid tibial tray sz 4f/5t (cat# 204-04-45 / serial# (b)(4)) three peg patella 41mm (cat# 200-02-41 / serial# (b)(4)) optetrak asy,ps cemented femoral, sz 4, (cat# 234-03-04 / serial# (b)(4)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
As reported by legal team, a 46 year old male patient had original surgery performed by a surgeon in newark, nj in 2014.Patient moved from nj to pa after the primary surgery.Patient has had two (2) revisions in pa with a surgeon and says had pain and issues following the primary surgery.When patient had first revision in 2017, the surgeon corrected a ¿patellar issue¿ (the patellar button was loose he thought), and ¿tightened the knee¿.However, only the insert was exchanged.The patient had continuing pain and mobility issues, then in (b)(6) 2021 had a second revision.Patient believes all the components were removed in 2021, and surgeon said he had significant lysis.Patient has had to work from home since the surgery, has leg length issues, continuing pain, etc.And has very limited mobility.No additional information.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent (b)(6) 2021 revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
The reason for the revision reported in incident may be the result of prosthesis wear and/or due to inclusion of the polyethylene in the packaging recall.However, prosthesis wear could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.Additionally, a contributing factor may have been the tibial insert being packaged in a non-conforming bag for more than five years.
Additional Manufacturer Narrative
H6: corrected health effect - clinical code, medical device problem code, component code, type of investigation, and investigation conclusions." the reason for the revision reported in incident may be the result of prosthesis wear and/or due to inclusion of the polyethylene in the packaging recall.However, prosthesis wear could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.Additionally, a contributing factor may have been the tibial insert being packaged in a non-conforming bag for more than five years.

• Brand Name: PS TIBIAL INSERTS SZ 4, 18MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14244061
• Report Number: 1038671-2022-00493
• Device Sequence Number: 20055427
• Product Code: JWH
• UDI-Device Identifier: 10885862048424
• UDI-Public: 10885862048424
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/08/2024

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: 04/12/2018
• Device Model Number: PS TIBIAL INSERTS SZ 4, 18MM
• Device Catalogue Number: 204-24-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 08/22/2022; 11/07/2024; Not provided
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 09/14/2022; 11/08/2024; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2010
• 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 THRU 0027-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male