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 Codes	Unstable (1667); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526); Unspecified Tissue Injury (4559); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 55 months after a right total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, joint pain, joint swelling and stiffness, loss of function, tissue damage, revision surgery, instability, and polyethylene liner dissociation.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitant devices: 3675845 188-00-07 - wedge plasma s/o sz 7 4905349 180-01-50 - nv crown cup clstr hole 50mm group 1 5119550 142-28-00 - cocr fem head 28mm +0 offset 12/14 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 the 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
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h11 the following sections were corrected: g1, h6.H11: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, meets the following risk criteria for early prosthesis wear and/or osteolysis as specified in an hhe: implanted with a component having a shelf age of greater than 2 years.The most likely underlying cause for the revision reported is prosthesis wear, disassembly, instability, and a combination of risk factors specified in an hhe.The cause of the reported disassembly cannot be conclusively determined but potential root causes include damage to the locking feature, wear of the acetabular liner, and/or patient-related factors.However, wear, disassembly, and instability 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 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 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19446271
• Report Number: 1038671-2024-01677
• Device Sequence Number: 16947362
• 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: 2018
• Device Explanted Year: 2022
• 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): 04/09/2026

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: 06/04/2019
• Device Catalogue Number: 130-28-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown