MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: lgc tibial fit tray cem sz 1.5f / 2.5t (cat# 02-012-45-1525 / serial# (b)(4)).Logic tib insert impl crc, sz 1.5, 11mm (cat# 02-012-51-1511 / serial# (b)(4)).Three peg patella 35mm (cat# 200-02-35 / serial# (b)(4)).Threaded pin size 2.3 collared 2pk (cat# 521-78-23 / serial# (b)(4)).Threaded pin size 2.3 collared 2pk (cat# 521-78-23 / serial# (b)(4)).Holding pin mini sharp point 4 pk (cat# 201-78-15 / serial# (b)(4)).Threaded pin size 3.0 collarless 2pk (cat# 521-78-32 / serial# (b)(4)).3" trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 17 months postop the initial implant, this (b)(6) y/o female patient had a revision due to instability and the surgeon upsized to 15mm insert.Patient was last known to be in stable condition following the event.Device not returning, hospital disposed of it.
Additional Manufacturer Narrative
H3: as reported, approximately 17 months postop the initial implant, this 68 y/o female patient had a revision due to instability and the surgeon upsized to 15mm insert.Patient was last known to be in stable condition following the event.Device not returning, hospital disposed of it.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.

• Brand Name: LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11779301
• Report Number: 1038671-2021-00214
• Device Sequence Number: 14426612
• Product Code: JWH
• UDI-Device Identifier: 10885862230294
• UDI-Public: 10885862230294
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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 Model Number: LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5
• Device Catalogue Number: 02-010-03-0315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 68 YR