MAUDE Adverse Event Report: EXACTECH, INC. INTEGRIP CC, CLUSTER 50MM, G1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	186-01-50
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 132-32-51 - nv gxl liner lipped 32mm id, group 1 cups.(b)(6) 101-45-30 - 4.5mm drill bit 30mm.(b)(6) 170-32-93 - biolox delta femoral head 32mm od, -3.5mm.(b)(6) 186-01-50 - integrip cc, cluster 50mm, g1.(b)(6) 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6) 188-01-04 - wedge plasma x/o sz 4.(b)(6) 180-65-25 - alteon 6.5mm screw, 25mm".The reason for the revision was not reported but is most likely the result of prosthesis wear and/or fracture of the acetabular liner leading to articulation between the femoral head and acetabular cup; the contributions of implant positioning and/or patient related factors to the sequence of events cannot be determined from the reported information; however, the 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) may have also been a contributing factor to the early prosthesis wear/fracture.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
As reported, this patient had a tha.The patient experienced complications, including but not limited to severe pain, difficulty in walking, metallosis, and a fractured liner.The patient then underwent a revision surgery, approximately 4 years, 8 months, after initial implant.There is no other patient demographic or medical history available.There is no device return.No additional information is available.

• Brand Name: INTEGRIP CC, CLUSTER 50MM, G1
• 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: 24349444
• Report Number: 1038671-2026-00153
• Device Sequence Number: 5066682
• Product Code: JDI
• UDI-Device Identifier: 10885862038760
• UDI-Public: 10885862038760
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: 186-01-50
• 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: 04/06/2023
• Initial Report FDA Received Date: 02/16/2026
• Date Device Manufactured: 02/21/2017
• 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 Sex: Unknown