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

Model Number	130-28-50
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 4476496, 164-13-08 - novation element ro s/o col sz 8.4548163, 142-28-03 - cocr fem head 28mm +3.5 offset 12/14.4556217, 180-65-20 - alteon 6.5mm screw, 20mm.4625391, 180-01-46 - cup, cluster-hole, 46mm group 0.Pending investigation.
Event or Problem Description
It was reported via legal documentation that a patient had and initial right hip arthroplasty on (b)(6) 2016 and then she had the right hip revised on (b)(6) 2022.The revision surgery was approximately 5 years, 8 months after initial implant.Revision operative report for failed right total hip replacement, revision of the acetabular component.A 71 yo female with a long history of right hip pain; complained of constant groin pain worse with weight bearing.X-rays showed a cup that appeared to have a significant area of wear and early osteolysis.The stem appeared well fixed.She had a workup for infection that was negative.Procedure: the ball head was removed from the trunnion which was inspected and found to be in excellent condition.The femur was the assessed and found to be well fixed and well positioned.There was bony ingrowth around the cup.Sterile dressing was applied.The patient was transferred to the recovery room in stable condition.The procedure was tolerated well and there were no intraoperative complications.The patient plan: discharge home with home health and follow-up for post op check at 6 weeks.
Additional Manufacturer Narrative
H3: investigation results - 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/or thinnest available acetabular liner was used.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of risk factors.However, this cannot be confirmed because the device was not returned for evaluation and images or radiographs were not provided.

• Brand Name: GXL NUETRAL LINER, G0 28MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: miguel sosa
• MDR Report Key: 16978231
• Report Number: 1038671-2023-01078
• Device Sequence Number: 6480901
• Product Code: LPH
• 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: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2026

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: 07/30/2021
• Device Model Number: 130-28-50
• Device Catalogue Number: 130-28-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 12/01/2023; 08/31/2026
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 12/13/2023; 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1731-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female