MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, NEUTRAL, 32MM ID, GROUP 4 CUPS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	130-32-54
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); Osteolysis (2377)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a male patient, who had a hip procedure, underwent a revision procedure approximately 10 years 4 months post the initial procedure.As part of the manufacturer's recall, the patient presented for a follow-up in 2023.X-rays and ct scans revealed moderate decentration of the prosthetic head and osteolysis in the acetabulum, indicating inlay wear.Due to the patient's comorbidities and the minimal signs of wear, a watchful waiting approach with regular follow-up visits was agreed upon.When symptoms suddenly worsened significantly at the end of 2024, a further follow-up visit was conducted, which revealed complete dislocation of the cup.The revision surgery was performed, including replacement of the entire cup (implantation of a revision cup with iliac peg from a competitor.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6 - 2374, 4627, 4118, 3233, 11 no longer applies.New codes added.No devices were returned for evaluation and no radiographs, images, operative notes, or patient medical history information were provided for review.It is possible this event is associated with polyethylene wear for which a number of variables including use error, implant positioning, implant selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) can be contributors.Additionally, increased shelf oxidation resulting from the use of nylon vacuum bags without evoh could also contribute to wear.Based on the available information, the revision may have been related to one or more of the contributors mentioned above.However, this cannot be definitively determined as the devices were not available for evaluation and radiographs, images operative notes, and patient medical history information were not provided for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, h6.Mdr section codes updated/corrected: e.The revision reported was likely the result of prosthesis wear and acetabular loosening and subsequent migration of the cup.The wear 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).The reason for the loosening cannot be confirmed, but may be related to the patient's bone quality and the reported osteolysis.However, this cannot be confirmed and the contributions of each to the sequence of events cannot be determined based on the information provided as no images, radiographs, or devices were available for review.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 4 CUPS
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 21965193
• Report Number: 1038671-2025-01970
• Device Sequence Number: 8414752
• Product Code: KWS
• UDI-Device Identifier: 10885862022189
• UDI-Public: 10885862022189
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2025

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: 04/19/2015
• Device Catalogue Number: 130-32-54
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 07/31/2025; 09/18/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 08/19/2025; 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2011
• 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: (B)(6). 180-01-60 - CROWN CUP, CLUSTER-HOLE GR.60.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male