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	12/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants medical products: 142-28-00 - sn (b)(4) cocr fem head 28mm +0 offset 12/14.No device return anticipated due to being a legal case.Recall number: z-2112 thru 2133-2021.
Event or Problem Description
It was reported via a legal filing, that a female patient who had underwent a revision of her right tha on (b)(6) 2017, suffered a dislocation of her right total hip replacement on (b)(6) 2017.She was treated with a closed reduction on or about (b)(6) 2017.Due to right groin pain at rest and with activity, she returned to her orthopedic surgeon for evaluation.On or about (b)(6) 2021, x-rays showed ¿abnormal superior wear of [her] polyethylene¿ liner and ¿evidence of osteolysis in the ischium and ilium.¿ her implanting orthopedist determined she would need revision surgery given the ¿extensive polyethylene wear and osteolysis.¿ repeat x-rays on or about (b)(6) 2021, revealed an almost completely worn-out liner and significant osteolysis behind the cup.¿ on or about (b)(6) 2021, her implanting orthopedist observed her (b)(6) 2021 ct scan demonstrated ¿extensive osteolysis with significant destruction of the posterior column¿ and again discussed revision surgery though ¿because of the history of 2 successive failures of the polyethylene within 4 years,¿ her implanting orthopedist indicated he ¿would need to be satisfied that changes have been made and the quality of the polyethylene would give a longer functional capability than 4 years.¿ on or about (b)(6) 2021, the surgeon who would perform her 2021 revision surgery discussed her need for revision surgery as the component ¿was recalled and is the culprit for her early osteolysis and poly[ethylene] breakdown.¿ on or about (b)(6) 2021, approximately 4 years 6 months post the revision surgery, the plaintiff underwent a second painful and risky revision surgery.Her polyethylene liner was removed and found to be ¿significantly worn.¿ she was found to have ¿bone defects.¿ cysts which ¿seemed to constitute most of [the] superior acetabulum.¿ the cysts were full of a ¿chalky white granular substance.¿.
Additional Manufacturer Narrative
H1: duplicate.This event was reported on 1038671-2021-00527.

• 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: 15324966
• Report Number: 1038671-2022-00973
• Device Sequence Number: 20135225
• 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: 2017
• Device Explanted Year: 2021
• 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: 04/02/2018
• 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: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female