MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL ALIP LNR G2 36MM; HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEME

Catalog Number	142-36-62
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Unspecified Musculoskeletal problem (4535)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 170-36-00 - biolox delta femoral head 36mm od, +0mm.(b)(6) 186-01-54 - integrip cc, cluster 54mm, g2.(b)(6) 190-21-07 - alt ha s noclr ext sz 7.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported approximately 80 months after bilateral total hip arthroplasty, a patient presented back to doctor's office with complaints of pain, stiffness and dissatisfaction with the right hip.Subsequently, the doctor noted that the patient technically had a recalled polyethylene.As a result, the patient was scheduled for a right hip revision six days later.It was noted that during the revision procedure the patient underwent an acetabular polyethylene swap and femoral head replacement.Intraoperatively, it was noted that the first polyethylene replacement component failed to lock into the acetabular component properly.It was removed; the remaining bone and soft tissue were removed around the rim of the cup and the second polyethylene was locked in properly.Post operatively it was noted there was a surgical delay/prolongation due to further dissection and debridement around the acetabular rim from the first replacement not locking in properly.It was reported there was no patient impact due to the surgical delay.The patient was last known to be in stable condition following the event.Images of the polyethylene explants were provided.No operative reports or medical records were provided.No additional information is available.

• Brand Name: NV EHXL ALIP LNR G2 36MM
• Common Device Name: HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEME
• 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: 22054684
• Report Number: 1038671-2025-02100
• Device Sequence Number: 15219397
• Product Code: OQI
• UDI-Device Identifier: 10885862537638
• UDI-Public: 10885862537638
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• 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): 05/20/2025

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: 08/27/2023
• Device Catalogue Number: 142-36-62
• 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: 05/18/2025
• Initial Report FDA Received Date: 05/20/2025
• Date Device Manufactured: 08/29/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female