MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3, 13MM; PROSTHESIS, WRIST, 2 PART METAL-PLASTIC ARTICULATION, SEMI-CONSTRAINED

Catalog Number	02-012-47-3013
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6) 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.(b)(6) 02-010-03-0330 - logic cr femoral cem, right, sz 3.(b)(6) 02-012-47-3013 - logic cr tib insert std, sz 3, 13mm.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.(b)(6) 02-010-03-0230 - logic cr femoral cem, left, sz 3.(b)(6) 200-02-32 - three peg patella 32mm.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.
Event or Problem Description
Legal case ¿ usa (mdl no.3044) (ngg) (mmh).Refer to (b)(4) for lk.It was reported that approximately 124 months after a right total knee replacement procedure, the patient has experienced prosthesis wear, plaintiff has suffered from pain, stiffness, swelling, discomfort, and instability which in turn negatively affected plaintiff's physical mobility and quality of life.Plaintiff required a right total knee revision surgery on (b)(6) 2023.Plaintiff went on to endure further pain during the recuperation period and required physical therapy.Plaintiff's ability to perform normal physical activities has been consequently limited.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Manufacturer narrative updated: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability and/or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3, 13MM
• Common Device Name: PROSTHESIS, WRIST, 2 PART METAL-PLASTIC ARTICULATION, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32606 6841
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 19995463
• Report Number: 1038671-2024-02872
• Device Sequence Number: 8363735
• Product Code: JWI
• UDI-Device Identifier: 10885862174369
• UDI-Public: 10885862174369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: 11/07/2019
• Device Catalogue Number: 02-012-47-3013
• 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: 11/01/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown