MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC FEMORAL PS CEM LEFT SZ 6
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Synovitis (2094)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 02-012-44-6011 - logic tibia implant psc insert, sz 6, 11mm; ***serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.(b)(6) 02-012-45-6050 - lgc tibial fit tray cem sz 6f / 5t; (b)(6) 200-02-38 - three peg patella 38mm.Pending investigation.
Event or Problem Description
As reported via legal documentation the male patient had a left knee replacement on (b)(6) 2015.Approximately 8 years after the initial procedure the patient had a left knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.Revision op report: 8 may 2023/(b)(4) received via legal 13 apr 2023.Diagnosis: failed left knee replacement.Findings: there was extensive soft tissue debris throughout the knee joint consistent with a synovitis from a polyethylene reaction to the tissues.This was tiny, small balls of light brown synovium along with a "pseudo-capsule" of dense soft tissue rind.The surgeon resected as much of this as safely possible.The total amount of soft tissue damage that required resection was about 20 oz.The surgeon examined the polyethylene - excessive wear was present with signs of oxidation/ yellow discoloration, pitting, cracking, and delamination of the poly.Distal femoral bone loss was severe but did not require a femoral cone.Extensive medial femoral bone loss with "golf ball" size bone loss - required 2 screws as rebar augmentation to support cement buildup.Loose femoral and tibial implants - removed easily with massive bone loss.The medial tibia had severe uncontained defect also "golf ball" size that required tibial cone placement.Patient reversed from anesthesia and sent to pacu in stable condition.
Additional Manufacturer Narrative
H6: investigation results - the revision reported may have been the result of polyethylene wear and aseptic loosening as stated in the operative notes.The aseptic (non-infected) loosening may have been the result of both patient-related conditions and insufficient bonds between the implants and the bones.The extent and root cause of the reported polyethylene wear cannot be determined as the explanted devices were not returned for evaluation, and radiographs / photographs were not provided.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 6
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16893912
• Report Number: 1038671-2023-00936
• Device Sequence Number: 20356376
• Product Code: JWH
• UDI-Device Identifier: 10885862173843
• UDI-Public: 10885862173843
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: 09/16/2019
• Device Model Number: LOGIC FEMORAL PS CEM LEFT SZ 6
• Device Catalogue Number: 02-010-01-0260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2011
• 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: A
• 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; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male