MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Model Number	NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: biolox ceramic 32 +0 head.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, during a scheduled revision case.Approximately 5 yrs post the initial left tha implant, this (b)(6) y/o female patient had a left gxl liner in with significant wear and was scheduled for revision.The surgeon took out a gxl group 1 32 liner extended liner and 32+0 biolox ceramic head.Surgeon replaced with a xle group 1 32 extended liner and a +3.5-delta adapter sleeve and 32 +0 delta biologic head.Patient was last known to be in stable condition following the event.The device will be returned.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of prosthesis wear of the acetabular liner due to edge loading, which may have possibly been related to the position of the cup.The most probable root cause associated with the reported event of " prosthesis wear" is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• Brand Name: NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11488034
• Report Number: 1038671-2021-00110
• Device Sequence Number: 19686400
• Product Code: JDI
• UDI-Device Identifier: 10885862207029
• UDI-Public: 10885862207029
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2019
• Device Model Number: NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
• Device Catalogue Number: 132-32-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/16/2021
• 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: 63 YR
• Patient Weight: 51