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

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right hip replacement on (b)(6)2022.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
D10.Concomitants: exactech cobalt chrome femoral head (142-28-93, 3856755) exactech element femoral stem (164-13-08, 3700673) novation crown cup acetabular shell 46mm (180-01-46, 4005508) exactech bone screw (180-65-20, 4008624) h6.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 revision reported was likely the result of a combination of both patient-related conditions and the risk factors specified in hhe2020-09-11-02.However, this cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.Initial submission: all fields in section f should be blank, this is a manufacturer's report.
Event or Problem Description
Additional information (op report): revision surgery: (b)(6) 2022 failed tka due to polyethylene wear and acetabular osteolysis.X-ray shows loosening, eccentric poly wear and acetabular and femoral osteolysis.Acetabular component well fixed.Bone loss in the acetabulum with osteolysis in the ilium and pubic bone.Revision right tha.The patient was transferred to the recovery room in stable condition after reversal of anesthesia.No device return anticipated due to this being a legal case.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 3523771140
• MDR Report Key: 17453034
• Report Number: 1038671-2023-01857
• Device Sequence Number: 20674139
• 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: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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: 10/09/2019
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 130-28-50
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2014
• 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: A
• 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: 57 YR
• Patient Sex: Female