MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-48-2009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case - usa (mdl no.3044) (ngg) (mmh).Patient id: frances valene lk rev.8.Plaintiff was implanted with the following exactech device: knee (optetrak/optetrak logic) 9.Leg in which the exactech device was implanted: left.10.Date the exactech device was implanted (see also note to paragraph 5 above): (b)(6) 2014.11.State in which the exactech device was implanted: al.12.Date the exactech device was surgically removed/revised: (b)(6) 2023 13.Plaintiff has suffered the following injuries and complications as a result of this exactech device: plaintiff has experienced daily pain and discomfort in her left knee which has limited her activities of daily living and impacted her quality of life.Plaintiff has suffered debilitating injuries and damages, including but not limited to, pain and discomfort; swelling; gait impairment; poor balance; component part loosening; soft tissue damage; bone loss; bone damage; and other injuries presently undiagnosed, which all require ongoing medical care.As a further direct, proximate, and legal consequence of the defective nature of the exactech device, plaintiff has sustained and will sustain future damages, including but not limited to cost of medical care; rehabilitation; home health care; loss of earning capacity; mental and emotional distress; and pain and suffering.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, and pending in the eastern district of new york.Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component, which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.No device return anticipated due to this being a legal case.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.No further information.2110348 02-012-48-2009 logic cr tib insert slope+, sz 2, 9mm.***serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.Udi: (b)(4).510k: k111400.Concomitant products: 2990365 - 02-010-03-0220 - logic cr femoral cem, left sz 2.3677507 - 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.Aa7042 - 13a2101 - cemex system fast genta 70g.3723784 - 200-02-29 - three peg patella 29mm.05 0120 14 003 - a10007 - gps knee implant kit.
Additional Manufacturer Narrative
D10 concomitant products: 2990365 - 02-010-03-0220 - logic cr femoral cem, left sz 2.3677507 - 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.Aa7042 - 13a2101 - cemex system fast genta 70g.3723784 - 200-02-29 - three peg patella 29mm.05 0120 14 003 - a10007 - gps knee implant kit.The product associated with the reported event is within the scope of recall z-0021-2022; 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.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 2, 9MM
• 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 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 19962064
• Report Number: 1038671-2024-02782
• Device Sequence Number: 21033535
• Product Code: JWH
• UDI-Device Identifier: 10885862174284
• UDI-Public: 10885862174284
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

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: 07/29/2019
• Device Catalogue Number: 02-012-48-2009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 08/12/2024
• Date Device Manufactured: 08/02/2011
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female