MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL NTRL LNR G4 36MM; HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEME

Catalog Number	140-36-54
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Joint effusion (4849)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was required, which in itself justifies the claim for pain it was reported via a legal notification, that a 68 yo male patient, who had an initial left hip implanted in (b)(6) 2019, and was revised in (b)(6) 2024, following a bicycle accident that resulted in a pelvic fracture in which the attending physicians had stated the fracture would not have occurred if the implanted hip joint had been free of defects, indicated that immediately following the rehabilitation, fluid accumulated in the affected joint, leading to significant impairment for the client.Since then, he has had to contend with both pain and limitations in his mobility and physical capacity, requiring additional physiotherapy measures.The client regularly took pain medication, beyond usual amounts, until the end of august 2024.Although the pain has subsided to the point that he stopped taking painkillers by the end of august, the limitations have not been fully resolved.Due to the fluid buildup, which in turn was caused by the preceding events, he continues to experience discomfort with specific movements that would otherwise be unproblematic.This fluid retention restricts his ability to climb stairs or bend down.He describes the sensation as if there is a cuff in the joint that limits his mobility and capacity.Due to these ongoing impairments, further examinations are scheduled at the hospital in westerstede.It is currently unclear whether these issues will resolve or remain permanent.No further information.(b)(6) 2024 revision reported under mdr 1038671-2024-00671.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3.The following sections were corrected: d1 h6.The cause of the patient¿s swelling and resulting decreased range of motion and limitations in his mobility reported cannot be conclusively determined but may be related to the revision surgery or to the reported trauma.However, the failure could not be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.The event as described appears unrelated to the design, manufacturing, or reasonably foreseeable misuse of the devices.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV EHXL NTRL LNR G4 36MM
• Common Device Name: HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEME
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 20610460
• Report Number: 1038671-2024-04233
• Device Sequence Number: 7930122
• Product Code: OQI
• UDI-Device Identifier: 10885862537331
• UDI-Public: 10885862537331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2024
• Device Catalogue Number: 140-36-54
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2019
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Male