MAUDE Adverse Event Report: EXACTECH, INC. ALT XLE LNR EXTCOV G5 36; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	01-030-42-0536
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6), 01-030-42-0536 - alt xle lnr extcov g5 36.(b)(6), 164-11-11 - novation element ro s/o sz 11.(b)(6), 170-36-07 - biolox delta femoral head 36mm od, +7mm.The revision reported was most likely due to prosthesis wear.However, no information was made available concerning the potential contributing factors of the reported wear.Additionally, the devices were not available for evaluation.Therefore, a definitive cause cannot be determined.Wear can be the result of implant placement, patient physical activity, patient health conditions or anatomic challenges, or unintentional interaction of the implant with third bodies such as bone or cement fragments.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that this female patient's left hip was revised approximately 2 years 3 months post op.The patient had an original exactech tha.The patient presented to doctors office with complaints of their left hip.The patient reported pain, instability, and dissatisfaction.It was noted and shown on the x-ray that the acetabular cup is not in an ideal position.The patient was scheduled for left hip revision with acetabular cup revision.The patient underwent left hip revision.During the revision, the femoral head was removed.The acetabular cup and liner were removed, the hip joint was debrided, and prepped for a new zb g7 cluster-hole cup.It was implanted with screws and a lipped liner.A new 36mm +10 mm head was implanted on the femoral stem.Reported event is not related to breakage of a device and did not lead to surgical delay/prolongation.Patient was last known to be in stable condition following the event.Product not returning: discarded at the facility.

• Brand Name: ALT XLE LNR EXTCOV G5 36
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22938642
• Report Number: 1038671-2025-02863
• Device Sequence Number: 13234767
• Product Code: LPH
• UDI-Device Identifier: 10885862549945
• UDI-Public: 10885862549945
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K182502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2026
• Device Catalogue Number: 01-030-42-0536
• 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: 05/15/2024
• Initial Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 04/12/2021
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female