MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM; PROSTHESIS, WRIST, 2 PART METAL-PLASTIC ARTICULATION, SEMI-CONSTRAINED

Catalog Number	02-012-44-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Bone Shedding Debris (4557); Swelling/ Edema (4577)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case - usa.It was reported that approximately 72 months after a total replacement procedure, the patient has experienced prosthesis wear.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Concomitant products: 4136622 - 02-010-01-0240 - logic femoral ps cem left sz 4.4165214 - 02-010-01-0340 - logic femoral ps cem right sz 4.3663372 - 02-012-35-4009 - logic tibia ps mod insrt sz 4 9mm.2928146 - 02-012-41-1010 - logic tibia traptray cem sz 1f/1t.4040341 - 02-012-41-4030 - logic tibia traptray cem sz 4f/3t.4195256 - 02-012-41-4040 - logic tibia traptray cem sz 4f/4t.(b)(6) - 02-012-44-2013 - logic tibia implant psc insert, sz 2, 13mm serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.(b)(6) - 02-012-44-4009 - logic tibia implant psc insert, sz 4, 9mm.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.4188754 - 142-28-00 - cocr fem head 28mm +0 offset 12/14.4160946 - 160-31-15 - pf spline plasma w/ha ext offset sz 15.4168429 - 200-02-32 - three peg patella 32mm.4200097 - 200-02-35 - three peg patella 35mm.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
H6: corrected health effect clinical code, type of investigation.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial loosening, 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 TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
• 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: 19987671
• Report Number: 1038671-2024-02844
• Device Sequence Number: 17883507
• Product Code: JWI
• UDI-Device Identifier: 10885862173638
• UDI-Public: 10885862173638
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 07/16/2023
• Device Catalogue Number: 02-012-44-4009
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2015
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male