MAUDE Adverse Event Report: EXACTECH, INC. INTEGRIP CC, CLUSTER 60MM, G4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	186-01-60
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Distress (2329); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2025-00721, 1038671-2023-00610 d10: 3738816 - 180-65-40 - alteon 6.5mm screw, 40mm 5139129 - 132-40-54 - nv gxl liner lipped 40mm id, group 4 cups 5336484 - 180-65-25 - alteon 6.5mm screw, 25mm 5665589 - 170-40-93 - biolox delta femoral head 40mm od, -3.5mm s002849 - 180-65-35 - alteon 6.5mm screw, 35mm s008593 - 180-65-30 - alteon 6.5mm screw, 30mm s008734 - 180-65-30 - alteon 6.5mm screw, 30mm multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-00721, 1038671-2023-00610.The revision reported may have been the result of prosthesis wear, osteolysis, acetabular cup loosening, and bone screw loosening as reported in the operative notes.The prosthesis wear may have been the result of the orientation of the acetabular cup, edge loading/impingement, patient-related conditions, or any combination of these possibilities.The aseptic (non-infected) acetabular loosening may have been the result of an insufficient bond between the acetabular cup and the bone, and the screw loosening may be secondary to the reported osteolysis.Additional contributing factors to the reported failures may have been the result of 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 as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that approximately 49 months after a left total hip replacement procedure, the patient underwent a revision procedure to address loosening, balance problems, ambulation difficulties, osteolysis, discomfort, distress, and pain.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.

• Brand Name: INTEGRIP CC, CLUSTER 60MM, G4
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21355636
• Report Number: 1038671-2025-00798
• Device Sequence Number: 18393093
• Product Code: JDI
• UDI-Device Identifier: 10885862038814
• UDI-Public: 10885862038814
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 02/11/2025

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: 06/16/2024
• Device Catalogue Number: 186-01-60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 02/11/2025
• Date Device Manufactured: 06/19/2014
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male