MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device: biolox delta option femoral head 28mm od (cat# 170-28-50 / serial# (b)(4)) biolox delta adapter 16/18-12/14; +3.5mm (cat# 170-50-03 / serial# (b)(4)) the 73 year old female patient involved was reported for revisions due to early prosthesis wear and subsequent osteolysis approximately 5.5 and 4.5 years after the respective index tha surgeries.The prosthesis wear was able to be confirmed from the provided radiographs.However, the explanted devices were not available for evaluation.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis, significant edge loading of the femoral head on the acetabular liner due to implant positioning, combination of largest available femoral head and/or thinnest available acetabular liner was used, and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision/monitoring reported due to early prosthesis wear/osteolysis is a combination of the risk factors including, use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential could have all contributed to the increased trend in wear/osteolysis related complaints).A risk assessment has been initiated to escalate this issue.
Event or Problem Description
The 73 year old female patient involved was reported for revisions due to early prosthesis wear and subsequent osteolysis approximately 5.5 and 4.5 years after the respective index tha surgeries.The prosthesis wear was able to be confirmed from the provided radiographs.However, the explanted devices were not available for evaluation.

• Brand Name: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15205076
• Report Number: 1038671-2022-00909
• Device Sequence Number: 2068377
• Product Code: JDI
• UDI-Device Identifier: 10885862022066
• UDI-Public: 10885862022066
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2022

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: 02/11/2019
• Device Model Number: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Device Catalogue Number: 130-28-51
• 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: 07/21/2022
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female