MAUDE Adverse Event Report: EXACTECH, INC. GXL NUETRAL LINER, G0 28MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	GXL NUETRAL LINER, G0 28MM ID
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 5 yrs postop the initial rtha, the female patient was revised, due to overtime the poly wore significantly by removing our cup and liner.The surgeon believed the instability of the hip may have caused cup loosening.Overtime the poly wore significantly.The acetabulum was revised with competitor implants.Patient was last known to be in stable condition following the event.The device will not be returned for analysis, sent to lab.
Additional Manufacturer Narrative
Section d10: concomitant medical products: cocr fem head 28mm +0 offset 12/14 (cat# 142-28-00 / serial# (b)(6)); novation element ro s/o col sz 10 (cat# 164-13-10 / serial# (b)(6)); cup, cluster-hole, 46mm group 0 (cat# 180-01-46 / serial# (b)(6)); alteon 6.5mm screw, 20mm (cat# 180-65-20 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received.(h3) 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.

• Brand Name: GXL NUETRAL LINER, G0 28MM ID
• 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: 12731900
• Report Number: 1038671-2021-00560
• Device Sequence Number: 1454492
• Product Code: JDI
• UDI-Device Identifier: 10885862022059
• UDI-Public: 10885862022059
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• 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: 06/06/2018
• Device Model Number: GXL NUETRAL LINER, G0 28MM ID
• Device Catalogue Number: 130-28-50
• 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: 10/11/2021
• Supplement Date Received by Manufacturer: 01/07/2022; 06/21/2022
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 01/11/2022; 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2013
• 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 Sex: Female