MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, 10 DEG FACE, 32MM ID, GRP 1 CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	138-32-51
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a left total hip arthroplasty on (b)(6) 2016, and then experienced revision surgical procedure on (b)(6) 2021 approximately 5 years and 5 months after initial implant.No images were provided.There is no other information available.
Additional Manufacturer Narrative
Concomitants: 101-05-03 - drill bit 1 pk 4.5mm dia x 32mm lng 3736455 142-32-93 - cocr fem head 32mm -3.5 offset 12/14 4270829 160-10-13 - pf stem taper plasma h/a sz 13 4158688 180-01-48 - nv crown cup clstr hole 48mm group 1 2571001 180-65-20 - alteon 6.5mm screw, 20mm 4341974 180-65-25 - alteon 6.5mm screw, 25mm 3728233 these devices are used for treatment and not diagnosis.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely underlying cause for the revision reported is prosthesis wear and fracture and a combination of risk factors: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed from the reported information and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV GXL LNR, 10 DEG FACE, 32MM ID, GRP 1 CUP
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18892852
• Report Number: 1038671-2024-00484
• Device Sequence Number: 6476287
• Product Code: LZO
• UDI-Device Identifier: 10885862024732
• UDI-Public: 10885862024732
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2017
• Device Catalogue Number: 138-32-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown