MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-36-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Unspecified Musculoskeletal problem (4535)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 186-01-58 - integrip cc, cluster 58mm, g3, (b)(6), 186-01-58 - integrip cc, cluster 58mm, g3, (b)(6), 101-05-30 - 3.2mm drill bit30mm 1pk, (b)(6), 170-36-00 - biolox delta femoral head 36mm od, +0mm, (b)(6), 170-36-00 - biolox delta femoral head 36mm od, +0mm, (b)(6), 180-65-30 - alteon 6.5mm screw, 30mm, (b)(6), 180-65-30 - alteon 6.5mm screw, 30mm, (b)(6), 188-00-08 - wedge plasma s/o sz 8, (b)(6), 188-00-08 - wedge plasma s/o sz 8.Customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a bilateral hip replacement.Subsequently, the patient experienced pain and stiffness.Upon physical and x-ray examination, both hips show poly thinning, indicating poly wear and osteolysis behind the acetabular cup implant, where the acetabular screw is located.A ct scan was also obtained, which shows the same results.There is concern for loosening of the acetabular cup implant.The poly liner is part of the recall.The surgeon planned for head/liner exchange with augmentation of bone graft behind the cups vs.A full cup revision.The hip joints were exposed, debrided, the femoral head removed.They checked the femoral stem for stability, removed the acetabular poly liner, removed the 6.5 x 30mm screw, and then injected a bone void filler substitute into the bone defect behind the cup.The hip joints were irrigated and debrided well.Surgeon implanted new poly acetabular lipped 40mm vitamin e liner and a 40mm +0 femoral head.The patient left the or stable.No further information available.

• Brand Name: NV GXL LNR, LIPPED, 36MM ID, GROUP 3 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23571540
• Report Number: 1038671-2025-03340
• Device Sequence Number: 10205695
• Product Code: JDI
• UDI-Device Identifier: 10885862023421
• UDI-Public: 10885862023421
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 11/17/2025

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: 03/31/2021
• Device Catalogue Number: 132-36-53
• 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: 10/31/2025
• Initial Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 04/13/2016
• 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
• Patient Age: 55 YR
• Patient Sex: Male