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 Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal brief, on or about (b)(6) 2018, patient underwent a right hip arthroplasty due to severe osteoarthritis in her right hip.Orthopedic surgeon utilized exactech products in patient right hip and did not breach any generally accepted standard of care in the field of orthopedic surgery in his care and treatment of patient negligently cause any injury to her.During the surgery on or about november 28, 2018, patient had an exactech novation crown cup system implanted in her right hip, which included the following exactech components (hereinafter "the device"): (1) 48 mm novation crown cup; (2) 28 mm novation gxl liner; (3) 28 mm biolox delta femoral head; and (4) size 1 alteon tapered wedge femoral stem.At the time of implant, each of the exactech components of patient's right hip was in substantially the same condition in all relevant respects as when they left defendants' control.On or about (b)(6) 2022, patient underwent right hip revision surgery due to right total hip dislocation and polyethylene wear.Surgeon noted in the revision operative report that "with the hip reduced on fluoro with a non-weightbearing film, you could still appreciate a slight eccentricity of the femoral head within the acetabular liner and cup, and this is suspicious for polyethylene wear".Patient continues to endure painful recovery and rehabilitation process from her revision surgery.
Additional Manufacturer Narrative
Concomitant products: biolox delta femoral head 28mm od, -3.5mm (cat# 170-28-93 / serial# (b)(4)).Cup, cluster-hole, 46mm group 0 (cat# 180-01-46 / serial# (b)(4)).Wedge plasma x/o sz 1 (cat# 188-01-01 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: investigation results - based on the available information, the patient meets the following risk criteria for early prosthesis wear/osteolysis: significant edge loading of the femoral head on the acetabular liner (dislocation) and 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 is a combination of risk factors.However, prosthesis wear cannot be confirmed as radiographs were not provided and the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, h6 - health effect - clinical code, medical device problem code, component code, h7 and h11 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Based on the available information, the patient meets the following risk criteria for early prosthesis wear/osteolysis: significant edge loading of the femoral head on the acetabular liner (dislocation) and 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 is a combination of risk factors.However, prosthesis wear cannot be confirmed.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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15988898
• Report Number: 1038671-2022-01605
• Device Sequence Number: 6103944
• Product Code: JDI
• UDI-Device Identifier: 10885862022059
• UDI-Public: 10885862022059
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K100269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

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: 11/06/2022
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 09/22/2023; 04/13/2026
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 10/04/2023; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2017
• 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
• 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; Hospitalization
• Patient Sex: Female