MAUDE Adverse Event Report: EXACTECH, INC. INTEGRIP CC, CLUSTER 58MM, G3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	186-01-58
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 15 months after a left total hip replacement procedure, the patient underwent a revision procedure to address loosening and pain.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
1038671-2023-00862 d10:: (b)(6) - 136-40-53 - novation gxl lnr +5 lat 40mm group 3 cups (b)(6) - 170-40-93 - biolox delta femoral head 40mm od, -3.5mm (b)(6) - 101-05-20 - 3.2mm drill bit 20mm 1pk (b)(6) - 190-31-12 - alt ha s clr ext sz 12 (b)(6) - 180-65-20 - alteon 6.5mm screw, 20mm (b)(6) - 180-65-20 - alteon 6.5mm screw, 20mm multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00862.The most likely underlying cause for the revision reported is prosthesis wear and acetabular loosening and a combination of risk factors specified: 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 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: INTEGRIP CC, CLUSTER 58MM, G3
• 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
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21230069
• Report Number: 1038671-2025-00386
• Device Sequence Number: 8302116
• Product Code: JDI
• UDI-Device Identifier: 10885862038807
• UDI-Public: 10885862038807
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

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 Catalogue Number: 186-01-58
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 01/24/2025
• Date Device Manufactured: 09/05/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male