MAUDE Adverse Event Report: EXACTECH, INC. ALT LNR TRL NEUT G7 40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Model Number	ALT LNR TRL NEUT G7 40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, after trial reduction and removal of the liner trial, it was noticed that the tip of the trial had been bent.Due to the damage of the locking mechanism of the liner, the surgeon did not feel comfortable using this liner trial in an upcoming case.With the bend of the center hole the liner, it would create an issue of having the liner fully seated.As a result of this, the liner trial will be returned.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of impacting the device off-axis during trialing, which resulted in the deformation on the mating feature.The most probable root cause associated with the reported event of "broken / non-functional" is associated with an undesired material change in shape or property caused by external forces.
Additional Manufacturer Narrative
Upon further review, this complaint was determined to be not reportable.The reported device malfunction did not cause or contribute to a serious deterioration in state of health or death and is not likely to cause or contribute to a serious deterioration in state of health or death if the malfunction were to recur.

• Brand Name: ALT LNR TRL NEUT G7 40
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11422597
• Report Number: 1038671-2021-00094
• Device Sequence Number: 14393745
• Product Code: JDI
• UDI-Device Identifier: 10885862554178
• UDI-Public: 10885862554178
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ALT LNR TRL NEUT G7 40
• Device Catalogue Number: 01-031-40-0740
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 03/22/2021; 04/08/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 03/28/2021; 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1