MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-22-13
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient has filed a long-form complaint in the circuit court of the eight judicial circuit in and for (b)(6).The patient alleges that as a direct and proximate result of the defective nature of the implant which necessitated premature removal, the patient suffered significant pain and discomfort, gait impairment, poor balance, difficulty walking, component part loosening, soft tissue damage, bone loss, mental and emotional distress.Per the information available in the legal documentation provided, the patient has not yet scheduled a surgery for explanation of the left knee at issue.The patient has had a right knee revision (b)(6) that is also covered in this legal longform.
Additional Manufacturer Narrative
D10 concomitant devices: (b)(6), 234-02-04 - optetrak asy,ps cemented femoral, sz 4, (b)(6), 204-38-08 - stem extension 80l x18 mm, (b)(6), 208-01-04 - cc femoral sz 4, (b)(6), 201-78-15 - holding pin mini sharp point 4 pk, (b)(6), 208-09-05 - cc stem ext adaptor 5 degree, (b)(6), 201-78-88 - 4"" drill bit, mod.Hex 2-pk, (b)(6), 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t, (b)(6), 200-02-38 - three peg patella 38mm.The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and loosening and/or 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, radiographs, and relevant clinical information 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, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19383597
• Report Number: 1038671-2024-01434
• Device Sequence Number: 3931184
• Product Code: JWH
• UDI-Device Identifier: 10885862048240
• UDI-Public: 10885862048240
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2020
• Device Catalogue Number: 204-22-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2012
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male