MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-48-3509
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Aseptic loosening (4883)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): (b)(4) 02-010-03-0235 - logic cr femoral cem, left, sz 3.5.(b)(4) 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t.(b)(4).200-02-29 - three peg patella 29mm.
Event or Problem Description
It was reported by the legal department, that this female patient's left tka was revised for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability, and/or component loosening.Patient experiences daily pain and discomfort in her left knee which limits her activities of daily living and impacts her quality of life.
Additional Manufacturer Narrative
Revision approximately 3 years, 10 months after initial implant.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 phot.H6: investigation-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 revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Event or Problem Description
It was reported by the legal department, that this female patient's left tka was revised for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability, and/or component loosening, approximately 3 years, 10 months after initial implant.Patient experiences daily pain and discomfort in her left knee which limits her activities of daily living and impacts her 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
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: b5, h6.H11: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.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 has 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.The tibial insert involved in this case was on the shelf for less than 1 year prior to implantation.However, while it was packaged in a non-conforming vacuum bag, this tibial insert was on the shelf for less than 5 years before it was implanted.A review of complaint history was performed and identified the sales data for all femoral components and tibial components was used to calculate a complaint occurrence rate of (b)(4) due to component loosening.The sales data for all patella components was used to calculate a complaint occurrence of (b)(4) due to component loosening.The sales data for all knee inserts was used to calculate a complaint occurrence of (b)(4) due to instability.Sales data for all knee inserts was used to calculate an approximate complaint occurrence rate of (b)(4) for prosthesis wear, which is considered low according to the frequency of occurrence ranking scale.Increased complaint rates for prosthesis wear is anticipated due to the product recall activities and resulting actions taken by surgeons and patients; no further escalation will be taken at this time.Monthly complaint trending will continue to monitor prosthesis wear events for potential trend signals and take action as required.Poly wear, instability and component loosening are known potential risks and are listed in the risk management documentation and ifu.A definitive root cause was unable to be determined; however, may be the result of poly wear, instability and component loosening or due to inclusion of the polyethylene in the packaging recall.However, the reported poly wear, instability and component loosening cannot be confirmed and potential contributions of manufacturing, 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 were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16395723
• Report Number: 1038671-2023-00185
• Device Sequence Number: 15061090
• Product Code: JWH
• UDI-Device Identifier: 10885862159281
• UDI-Public: 10885862159281
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2026

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: 08/16/2019
• Device Catalogue Number: 02-012-48-3509
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 04/21/2023; 03/18/2026
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 04/21/2023; 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2011
• 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-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female