MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-2509
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Swelling/ Edema (4577)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: (b)(6), 200-02-35 - three peg patella 35mm.(b)(6), 02-010-01-0325 - logic femoral ps cem right sz 2.5.(b)(6), 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t.(b)(6), 201-78-88 - 4"" drill bit, mod.Hex 2-pk.(b)(6), 201-78-88 - 4"" drill bit, mod.Hex 2-pk.The product associated with the reported event is within the scope of recall z-0021-022; 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.
Event or Problem Description
Legal case ¿ usa (mdl no.3044) (ngg) (mmh).Patient id: iris shoots rk 1st rev.Refer to (b)(4) rk 2nd rev.8.Plaintiff was implanted with the following exactech device: knee.9.Leg in which the exactech device was implanted: right.10.Date the exactech device was implanted: (b)(6) 2016.11.State in which the exactech device was implanted: (b)(6).12.Date the exactech device was surgically removed/revised: 2018.13.On (b)(6) 2016, plaintiff underwent a right total knee arthroplasty in which an exactech optetrek logic device was implanted.In 2018, plaintiff underwent a right total knee arthroplasty revision.Plaintiff suffered from pain, swelling, and decreased range of motion.The implantation of the exactech device and subsequent revisions have caused personal injuries, severe pain and suffering, mental anguish, emotional distress, fear, loss of enjoyment of life, medical expenses, and financial losses, and she will sustain future damages including but not limited to cost of medical care, rehabilitation, mental and emotional distress, and pain and suffering.Accordingly, plaintiff is seeking compensatory and special damages, including attorneys' fees and costs, and all other available remedies under the law.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044 (ngg) (mmh), and pending in the eastern district of (b)(6).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.Serial number, item number and full description: (b)(6), 02-012-35-2509 - logic tibia ps mod insrt sz 2.5 9mm.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510(k): k093360.Concomitants; (b)(6), 200-02-35 - three peg patella 35mm.(b)(6), 02-010-01-0325 - logic femoral ps cem right sz 2.5.(b)(6), 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t.(b)(6), 201-78-88 - 4" drill bit, mod.Hex 2-pk.(b)(6), 201-78-88 - 4" drill bit, mod.Hex 2-pk.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, loss of range of motion or due to 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: LOGIC TIBIA PS MOD INSRT SZ 2.5 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: 19938813
• Report Number: 1038671-2024-02742
• Device Sequence Number: 14690810
• Product Code: JWH
• UDI-Device Identifier: 10885862001764
• UDI-Public: 10885862001764
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• 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): 12/04/2024

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: 10/13/2023
• Device Catalogue Number: 02-012-35-2509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2015
• 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: Required Intervention; Hospitalization
• Patient Sex: Female