MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-28-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ usa (mdl no.3044).(b)(4) lh is associated with this case.It was reported via legal documentation that approximately 52 months after a right total hip replacement procedure, the patient has experienced prosthesis wear, pain, stiffness, ambulatory problems, joint pain and weakness, osteolysis, past and future medical expenses, past and future lost wages, loss of earning capacity, mental suffering and anguish, pain and suffering.No further issues or complications were reported.No additional information is available.Unable to confirm specific devices due to bilateral ebi invoice data.The serial number (b)(6) are confirmed to be a part of recall number: z-1729-2022.
Additional Manufacturer Narrative
Concomitants: (b)(6) 186-01-48 - integrip cc, cluster 48mm, g1 (b)(6) 186-01-50 - integrip cc, cluster 50mm, g1 (b)(6) 180-65-30 - alteon 6.5mm screw, 30mm (b)(6) 180-65-30 - alteon 6.5mm screw, 30mm (b)(6) 190-30-03 - alt ha s clr std sz 3 (b)(6) 190-30-03 - alt ha s clr std sz 3 (b)(6) 170-28-00 - biolox delta femoral head 28mm od, +0mm (b)(6) 170-28-00 - biolox delta femoral head 28mm od, +0mm.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 device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
Based on the available information, the patient meets the following risk criteria for early prosthesis wear and/or osteolysis: implanted with a lateralized liner, combination of largest available femoral head and/or thinnest available acetabular liner was used and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the reported revision due to prosthesis wear and osteolysis may have been 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 as the devices were not returned for evaluation, and images and radiographs were not provided.H6: corrected health effect clinical codes.

• Brand Name: NV GXL LINR, NTRL, 28MM ID, GROUP 1 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20430707
• Report Number: 1038671-2024-03952
• Device Sequence Number: 15360364
• Product Code: JDI
• UDI-Device Identifier: 10885862022066
• UDI-Public: 10885862022066
• 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: 2020
• 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,Followup
• Report Date (Section B): 02/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 130-28-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 02/06/2025
• 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.
• Patient Sex: Unknown