MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial tha on an unknown date.The patient was revised due to wear.The cup was removed and a competitor's device was implanted.An exactech head was used.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
Additional information: d1, d4, d6a, d10, h4, h6 component code.Corrected data: section d7 updated from ¿yes¿ to ¿no¿.D10: (b)(6) 101-05-20 - 3.2mm drill bit 20mm 1pk.(b)(6) 170-36-00 - biolox delta femoral head 36mm od, +0mm.(b)(6) 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6) 186-01-52 - integrip cc, cluster 52mm, g2.(b)(6) 190-31-03 - alt ha s clr ext sz 3.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d.The most likely cause for the revision reported due to early prosthesis wear is a combination of the 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).Additionally, the sequence of events as related to the reported wear cannot be confirmed and the contributions of each to the reported event cannot be determined.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, +5LAT, 36MM G2-52/54MM 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, INC.; 2320 nw 66th ct; gainesville FL
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20044534
• Report Number: 1038671-2024-03030
• Device Sequence Number: 18136863
• Product Code: JDI
• UDI-Device Identifier: 10885862024329
• UDI-Public: 10885862024329
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2025

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: 03/13/2022
• Device Catalogue Number: 136-36-52
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 08/21/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/11/2024; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown