MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-32-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.D10: 4179599 180-01-56 - crown cup, cluster-hole.H7: z-2117-2021.
Event or Problem Description
As part of the manufacturer's recall campaign, the patient presented for a new check-up.In the x-ray and ct control showed the well-known clear decentering of the prosthetic head and a clear increase in size of the known lysis in the acetabulum.That's why the revision and change took place on (b)(6) 2024 on a vite-hardened, specially approved inlay (novation xle neutral liner, group 3, 36 mm i.D., ref 140-36-53, sn: (b)(6).As part of the replacement operation, in addition to the inlay replacement, the firmness was determined cup integrity as well as the curettage and sealing of the cysts in the socket using allogeneic cancellous bone and changing the prosthetic head.
Additional Manufacturer Narrative
H3: a number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis related complaints.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the risk factors specified in the hhe.However, this cannot be confirmed from the reported information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely cause for the revision reported due to early prosthesis wear/osteolysis 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 from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: e.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b5, d4.The following sections were corrected: h6.
Event or Problem Description
It was reported via ous legal documentation that a patient underwent a total hip replacement.During the subsequent assessments and examinations conducted by the hospital it was determined that the prosthetic head required revision.It became apparent that the plastic inlay had already suffered significant wear and tear, and there was a risk that the plastic particles from the dissolving implant could damage the surrounding bone.For this reason, our client had to undergo a maximally invasive revision surgery, followed by several weeks of postoperative treatment.Intraoperatively, premature wear of the inlay was confirmed.Since the replacement of the defective hip prosthesis and the bone damage caused by the material, the patient has experienced severe pain during prolonged normal activity, such as walking.As a result, normal movement has been severely limited since then.This, in turn, has had a huge impact on the performance of daily tasks and social activities and has significantly reduced the patient's quality of life.The patient has suffered from severe pain and restricted mobility.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: 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 definitive root cause was unable to be determined; however, may have resulted from use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).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 LNR, NEUTRAL, 32MM ID, GROUP 3 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: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18927394
• Report Number: 1038671-2024-00547
• Device Sequence Number: 14581129
• Product Code: JDI
• UDI-Device Identifier: 10885862022172
• UDI-Public: 10885862022172
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 130-32-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 05/22/2024; 12/13/2024; 05/14/2025; 02/06/2025; 08/29/2025
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 05/29/2024; 12/16/2024; 05/14/2025; 08/15/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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: Hospitalization; Required Intervention
• Patient Sex: Male