MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; GXL NUETRAL LINER, G0 28MM ID

Model Number	130-28-50
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); No Code Available (3191); Muscle/Tendon Damage (4532); Bursitis (4832)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.(concomitant device(s): femoral head 28 (cn: 142-28-00 / sn; (b)(4)) , vastago element (cn: 164-01-10 / sn: (b)(4)), crown cup 46mm (cn: 180-11-46 / sn: 2067133).
Event or Problem Description
Premature wear of polyethylene.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported may have been the result of edge loading/impingement and/or patient conditions which led to prosthesis wear.However, this cannot be confirmed because the component was not returned for evaluation.(d11) concomitant device(s): femoral head 28 (cn: (b)(4), sn; (b)(6).Vastago element (cn: (b)(4), sn; (b)(6).Crown cup 46mm (cn: (b)(4), sn; (b)(6).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a3, b5, d6b, h6 (clinical code, impact code, component code, investigation codes) the device was not returned for analysis.Investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
Additional information was received that the patient experienced bursitis, cyst, and rupture of a tendon.It was confirmed that the hip was subsequently revised.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: 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/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 reported due to early prosthesis wear is a combination of the risk factors specified in an hhe.The prosthesis wear was able to be confirmed from the provided radiograph.H6 (type of investigation, investigation findings, investigation conclusion).

• Brand Name: NOVATION
• Common Device Name: GXL NUETRAL LINER, G0 28MM ID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523782617
• MDR Report Key: 9342982
• Report Number: 1038671-2019-00573
• Device Sequence Number: 2739653
• Product Code: JDI
• UDI-Device Identifier: 10885862022059
• UDI-Public: 10885862022059
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/09/2025

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: 06/14/2014
• Device Model Number: 130-28-50
• Device Catalogue Number: 130-28-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 04/01/2020; 09/01/2023; 04/04/2025
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 04/21/2020; 01/08/2025; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2010
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female