MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number	136-36-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Distress (2329)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2018, with no revision surgery reported.No radiographic images of the device are provided.There is no other information available.
Additional Manufacturer Narrative
Concomitants: 101-05-20 - 3.2mm drill bit 20mm 1pk (b)(6) 170-36-93 - biolox delta femoral head 36mm od, -3.5mm (b)(6) 180-65-20 - alteon 6.5mm screw, 20mm (b)(6) 180-65-20 - alteon 6.5mm screw, 20mm (b)(6) 186-01-56 - integrip cc, cluster 56mm,g3 (b)(6) 190-30-08 - alt ha s clr std sz 8 (b)(6).These devices are used for treatments, not diagnosis.There is no other information available.
Additional Manufacturer Narrative
Manufacturer narrative: based on the available information, the patient involved in the incident meets the following risk criteria for early prosthesis wear and/or osteolysis: implanted with a lateralized liner.The most likely cause for the reported 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).However, this cannot be confirmed as the devices were not available for evaluation, and images or radiographs were not provided.At this time, it does not appear that the patient¿s right hip has been revised.

• Brand Name: NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• 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: matt collins
• MDR Report Key: 19170088
• Report Number: 1038671-2024-00958
• Device Sequence Number: 7435897
• Product Code: LZO
• UDI-Device Identifier: 10885862024336
• UDI-Public: 10885862024336
• 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: 2018
• 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): 09/06/2024

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: 03/25/2023
• Device Catalogue Number: 136-36-53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2018
• 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
• 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