MAUDE Adverse Event Report: EXACTECH, INC. ALT XLE LNR NTRL G7 36; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ALT XLE LNR NTRL G7 36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, a patient had a right anterior hip replacement on (b)(6) 2021 the patient dislocation anteriorly while bending backwards and pushing his hips forwards.The male patient was revised, and the cup was removed so that he could implant a cup with dual mobility.Utilizing lateral standing and sitting xrays, the surgeon determined that the patient had an anatomically fused spine and his hip replacement impinged posteriorly due to his lack of pelvic motion at the l5-s11 joint.
Additional Manufacturer Narrative
After further review of additional information received the following sections d6a, g3, g7 and h2 have been updated accordingly.Section d6a: implant date.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2 and h6 have been updated accordingly.As reported, a patient had a right anterior hip replacement on (b)(6) 2021.The patient dislocation anteriorly while bending backwards and pushing his hips forwards.The male patient was revised, and the cup was removed so that he could implant a cup with dual mobility.Utilizing lateral standing and sitting xrays, the surgeon determined that the patient had an anatomically fused spine and his hip replacement impinged posteriorly due to his lack of pelvic motion at the l5-s11 joint.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 the dislocation and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament re-construction.

• Brand Name: ALT XLE LNR NTRL G7 36
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12052359
• Report Number: 1038671-2021-00306
• Device Sequence Number: 14542837
• Product Code: JDI
• UDI-Device Identifier: 10885862549709
• UDI-Public: 10885862549709
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2021

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 Model Number: ALT XLE LNR NTRL G7 36
• Device Catalogue Number: 01-030-40-0736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 09/21/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/27/2021; 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability