MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL NTRL LNR G1 32MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV EHXL NTRL LNR G1 32MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately one month post tha, there was a change in treatment.After the revision operation (b)(6) 2022, patient reported instability with two dislocations, so on (b)(6) 2022 the xle inlay was changed to a 20° shoulder inlay.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) it was reported from a foreign regulatory body that a patient had a change in treatment related to a hip replacement surgery.¿with regard to the patient's uti ((b)(6)), there was a change in treatment.After on (b)(6) 2022 the revision operation reported resulted in instability with two dislocations, so on (b)(6), 2022 the xle inlay was changed to a 20° shoulder inlay.¿ no additional information is available.The devices will not be returned.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision for instability cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: NV EHXL NTRL LNR G1 32MM
• 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: 15088518
• Report Number: 1038671-2022-00836
• Device Sequence Number: 3879425
• Product Code: JDI
• UDI-Device Identifier: 10885862537263
• UDI-Public: 10885862537263
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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: 02/10/2026
• Device Model Number: NV EHXL NTRL LNR G1 32MM
• Device Catalogue Number: 140-32-51
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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: Unknown