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

Catalog Number	204-22-11
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Event or Problem Description
As reported, the 76 year old female patient had an initial tka in 2010.The patient has been experiencing swelling, pain, and what felt like a poking sensation in her knees.X-ray studies showed a slight inclination in the tibial implant.We have regularly monitored the x-ray reports which showed worsening.The patient was revised for suspected osteolysis.Additional details pending.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of osteolysis and aseptic loosening as stated in the documentation.The aseptic (non-infected) tibial loosening may have been the result of a combination of patient-related conditions and insufficient bonds between the tibial tray and the bone.However, the osteolysis and tibial loosening cannot be confirmed as the explanted devices were not returned for evaluation.H7: z-0019-2022.Additional information: h6 clinical code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d4, h4.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b5, g4.The following sections were corrected: b3, h6, h11.No device was returned for evaluation; radiograph images were provided; however, the reported event was unable to be confirmed.The review identified that there appears to be an area of bone loss along the medial aspect of the tibial bone.However, this cannot be confirmed from the information provided.Tibial loosening and prosthesis wear of the tibial insert cannot be evaluated as product images, initial post-operative radiographs, and pre-revision radiographs were not provided.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was performed and identified that a bag used in the packaging of our polyethylene inserts had been produced outside of our quality specifications.The use of these non-conforming bags may enable increased oxygen diffusion to the uhmwpe (ultra-high molecular weight polyethylene) insert, resulting in increased oxidation of the material relative to inserts packaged with bags that conform to exactech¿s specifications.For inserts with greater than five years of shelf life, increased oxidation of the inserts can lead to premature polyethylene wear resulting in a revision surgery.However, it cannot be confirmed whether these tibial inserts were packaged in a non-conforming bag since manufacturing information was not available for this device.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from tibial loosening and prosthesis wear of the polyethylene component.It remains unclear if the reported loosening contributed to the reported instability.However, prosthesis wear, tibial loosening, and instability cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and product images, initial post-operative radiographs, and pre-revision radiographs were not provided.
Event or Problem Description
Additional information received indicates the patient was complaining of pain and instability in their left knee.No history of fall, no history of fever.Upon examination a varus deformity, limpness and laxity were seen in the left knee.Painful range of movement noted.No signs of local inflammation.X-ray showed severe osteolysis, bone loss with implant loosening on the tibial side with peri-prosthetic osteolysis on the femoral side.

• Brand Name: PS TIBIAL INSERTS SZ 2, 11MM
• 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; 2320 nw 66th court; gainesville 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19122557
• Report Number: 1038671-2024-00882
• Device Sequence Number: 7628989
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/17/2026

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 Expiration Date: 02/26/2017
• Device Catalogue Number: 204-22-11
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 08/01/2024; 03/03/2026; 02/26/2026
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 08/26/2024; 03/13/2026; 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2009
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Age: 76 YR
• Patient Sex: Female