MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical devices: 142-28-93 - sn (b)(4) cocr fem head 28mm -3.5 offset 12/14, 160-00-13 - sn (b)(4) pf stem tapered plasma sz 13, 180-01-48 - sn (b)(4) nv crown cup clstr hole 48mm group 1.No device return anticipated due to it being a legal case.
Event or Problem Description
It was reported via a legal filing, that a female patient who had a right tha on or about (b)(6) 2013, began feeling pain and discomfort and returned to her orthopedist.On (b)(6) 2016, a ct scan revealed ¿some liner wear within the acetabulum¿ and ¿evidence of osteolysis along the superior aspect of the acetabulum.¿.The pain progressed and records reflect that by (b)(6) 2017 the pain evolved to the point where the patient was in so much pain that she was not ¿able to go to work or sleep.¿ on or about (b)(6) 2017, approximately 4 years 1 month post the initial procedure, the plaintiff underwent painful and risky right total hip replacement revision surgery to remove the defective gxl liner due to ¿eccentric poly[ethylene] wear.¿ her gxl liner and femoral head were removed and she was implanted with a new novation crown cup size 28 neutral connexion gxl liner and size 28 mm +0 femoral head.
Additional Manufacturer Narrative
H1: 1038671-2022-00974 is a duplicate.This event has already been reported on 1038671-2017-00272.

• Brand Name: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• 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 ; 3523771140
• MDR Report Key: 15325080
• Report Number: 1038671-2022-00974
• Device Sequence Number: 12052579
• Product Code: JDI
• UDI-Device Identifier: 10885862022066
• UDI-Public: 10885862022066
• Combination Product (Y/N): N
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: 11/03/2013
• Device Model Number: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Device Catalogue Number: 130-28-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2009
• 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