MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 60MM GROUP 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	180-01-60
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
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 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.On (b)(6) 2025, 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 and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: a, 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/additional information.The following sections were correct: d10, h6 2374, 4627, 4756 no longer applies, the following sections were updated: d4, g4 510k, h3, h4, h6.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, may have resulted from 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).Additional reasons for revision may be acetabular loosening, subsequent migration and being implanted for more than 10 years.However, this 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 CROWN CUP CLSTR HOLE 60MM GROUP 4
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21965199
• Report Number: 1038671-2025-01971
• Device Sequence Number: 8414755
• Product Code: JDI
• UDI-Device Identifier: 10885862037053
• UDI-Public: 10885862037053
• 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: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,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: 03/07/2019
• Device Catalogue Number: 180-01-60
• 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: 08/13/2025; 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2014
• 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: 130-32-54 NV GXL LNR, NEUTRAL, 32MM ID, GROUP 4 CU.; 2988892 180-01-60 - CROWN CUP, CLUSTER-HOLE GR.60.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male