MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 13MM; SEE H10

Model Number	204-24-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported from the legal department, approximately 2 years post op the first revision of the right tka, this male patient was revised due polyethylene liner wear with resulting metallosis, osteolysis, and aseptic loosening of the femoral component.It is stated that despite undergoing the revision surgeries, patient experiences daily knee pain and discomfort which limit patient activities of daily living and recreation and impacts patients quality of life.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
Common device name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - concomitants: 3685982 204-40-08 - stem extension 80l x20 mm.3677256 208-01-04 - cc femoral sz 4.3580612 208-05-04 - cc distal fem augment sz 4, 5mm.3580616 208-05-04 - cc distal fem augment sz 4, 5mm.2744026 208-06-04 - cc distal fem augment sz 4, 10mm.3577482 208-06-04 - cc distal fem augment sz 4, 10mm.2830365 208-08-04 - cc posterior fem augment sz 4, 10mm.3580406 208-08-04 - cc posterior fem augment sz 4, 10mm.3752636 208-09-05 - cc stem ext adaptor 5 degree.Aa5648r tpa-24 - cement restrictor large.Pending investigation.
Event or Problem Description
Additional information- revision surgery of (b)(6) 2016- failed right total knee secondary to polyethylene failure with metallosis.Subtotal synovectomy taking out all metallosis in this synovial tissue.The femur was also grossly loose and disassociated with the entire stem in one piece.The lateral condyle was essentially nonunion with significant bone loss all the way up past the lateral collateral ligament structures.The medial side ulcer showed a significant amount of osteolysis around the condyle so a decision was made to do a distal femoral replacement.The patient had no complications during the case.He was taken to the pacu without incident.There is no other information available.
Additional Manufacturer Narrative
(h3) the revision reported may have been due to polyethylene wear of the tibial insert, which resulted in metallosis, osteolysis, and aseptic loosening of the femoral component as stated in the legal documentation.The extent and root cause of the reported prosthesis wear cannot be determined as the device(s) were not available for evaluation, and photographs of the explanted device(s), radiographs, and operative notes were unable to be obtained.However, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.These devices are used for treatment not diagnosis.

• Brand Name: PS TIBIAL INSERTS SZ 4, 13MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16635949
• Report Number: 1038671-2023-00537
• Device Sequence Number: 20643917
• Product Code: JWH
• UDI-Device Identifier: 10885862048400
• UDI-Public: 10885862048400
• 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: 2014
• Device Explanted Year: 2016
• 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
• Report Date (Section B): 09/13/2023

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: 08/19/2012
• Device Model Number: 204-24-13
• Device Catalogue Number: 204-24-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2007
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male