MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-32-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: (b)(6) 186-01-54 - integrip cc, cluster 54mm, g2.(b)(6) 164-03-11 - element-stem, collared w/ha, std offset, sz 1.(b)(6) 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6) 142-32-03 - cocr fem head 32mm +3.5 offset (b)(6).The product associated with the reported event is within the scope of recall z-1729-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The prosthesis wear reported may have been due to 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.
Event or Problem Description
As reported via legal documentation the patient had a left hip replacement on (b)(6) 2017.The device has not been explanted.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: NV GXL LINR, NTRL, 32MM ID, GROUP 2 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 20852866
• Report Number: 1038671-2024-04635
• Device Sequence Number: 18167753
• Product Code: JDI
• UDI-Device Identifier: 10885862022165
• UDI-Public: 10885862022165
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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: 12/14/2021
• Device Catalogue Number: 130-32-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 12/05/2024
• Date Device Manufactured: 12/16/2016
• 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: Required Intervention
• Patient Sex: Unknown