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

Model Number	N/A
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products - 28+0 cocr head - 20mm bone screw.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately seven years post initial left tha, the 72 y/o female patient was brought back for left hip pain.The femur was dislocated, femoral head removed, stem was well fixed.Attention turned to the cup.The liner was removed with the use of a bone screw.The acetabular screw was removed, cup checked and found to be well fixed.The patient received a group 0 xle lipped liner with a 28 + 3.5 head.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays received.Sales rep was unable to obtain photos.The devices are not available for evaluation due to patient requested implants.
Additional Manufacturer Narrative
H3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: combination of largest available femoral head and thinnest available acetabular liner was used.The most likely cause for the revision reported due to early prosthesis wear and pain is a combination of the risk factors specified in the hhe.The prosthesis wear was able to be confirmed from the provided radiograph.Correction: h6 problem code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-1731-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.D10 concomitant devices: 4317578 180-65-20 - alteon 6.5 mm screw, 20 mm; 4740859 142-28-00 - cocr fem head 28 mm +0 offset 12/14; 4772402 180-01-46 - cup, cluster-hole, 46 mm group 0; 4793028 164-13-10 - novation element ro s/o col sz 10".Based on the available information, the patient involved in incident meets the following risk criteria for early prosthesis wear/osteolysis: combination of largest available femoral head and thinnest available acetabular liner was used.The most likely cause for the revision reported due to early prosthesis wear and pain is a combination of the risk factors such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).The prosthesis wear was able to be confirmed from the provided radiograph.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 18912415
• Report Number: 1038671-2024-00521
• Device Sequence Number: 7042377
• Product Code: JDI
• UDI-Device Identifier: 10885862022059
• UDI-Public: 10885862022059
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2022
• Device Model Number: N/A
• 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: 02/18/2024
• Supplement Date Received by Manufacturer: 08/19/2024; 08/19/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 09/04/2024; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2017
• 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: 72 YR
• Patient Sex: Female