MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	02-010-01-0360
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
**08-aug-2024 additional summary** it is reported via legal documentation that patient underwent rk revision (b)(6) 2024.(op report attached).Clinical history: patient presents with failed right total knee replacement in the setting of recalled implant, with osteolysis of the distal femur and he proximal tibia.Pre/postoperative diagnosis: status post right total knee replacement; distal femur and proximal tibia osteolysis.Procedure: revision total knee replacement femoral and tibial components operative notes: knee joint exposed.Patella was dislocated laterally and found to be stable.Insert was removed.Femoral component was found to be loose.Bony inventory after removal of the femoral component revealed aori type 2b bone loss.Tibial component was then removed, during this time a small defect was noted in the posterior cortex of the proximal tibia, which was later filled with cerament.Bony inventory after removal cement of the tibia revealed aori type 1 bone loss.Trial components were sized, then removed.Cerament was used to fill the defect in the posterior tibial cortex.Bony surfaces were then irrigated and dried.Implants were impacted.Patient was transferred to the recovery room in stable condition.The serial number 4455716 is confirmed to be a part of recall number: z-0021-2022.02-012-44-6011 - logic tibia implant psc insert, sz 6, 11mm.Serial: (b)(6).510k: k110547.Udi: (b)(4).Product code: jwh.X-ray: no.Operative notes: no.Concomitant devices: 5032910 02-010-01-0360 - logic femoral ps cem right sz 6.4205671 02-012-41-6050 - logic tibia traptray cem sz 6f/5t.5484338 200-02-38 - three peg patella 38mm.3609305 201-78-12 - holding pin lg head sharp point med 2pk.**original summary** it was reported via legal documentation that approximately 71 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, stiffness, discomfort, and weakness, negatively affected mobility and quality of life, revision surgery; pain following surgery and during the rehabilitation period, physical therapy; limited ability to perform normal physical activities.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10 concomitant devices 5032910 02-010-01-0360 - logic femoral ps cem right sz 6.4205671 02-012-41-6050 - logic tibia traptray cem sz 6f/5t.5484338 200-02-38 - three peg patella 38mm.3609305 201-78-12 - holding pin lg head sharp point med 2pk.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.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening 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 and radiographs were not provided.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 6
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 19947963
• Report Number: 1038671-2024-02754
• Device Sequence Number: 18168780
• Product Code: JDI
• UDI-Device Identifier: 10885862001276
• UDI-Public: 10885862001276
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 08/20/2022
• Device Catalogue Number: 02-010-01-0360
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• 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 Age: 67 YR
• Patient Sex: Male