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

Model Number	INTEGRIP CC, CLUSTER 50MM, G1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products.Alt ha s clr ext sz 8 (cat# 190-31-08 / serial# (b)(4)).Biolox delta femoral head 28mm od, +3.5mm (cat# 170-28-03 / serial# (b)(4)).Nv gxl linr, ntrl, 28mm id, group 1 cups (cat# 130-28-51 / serial# (b)(4)).As reported, approximately 19 months postop the initial right hip tha, this (b)(6) y/o female patient had a total hip prosthesis removed and revised due to infection.The patient was revised to a competitor¿s components.The device will not be returned for evaluation due to hospital kept the devices.Patient was last known to be in stable condition following the event.Per ifu# 700-096-018 - infection is a known complication following total joint replacement surgery and can be multifactorial.Postoperative counseling and care are important.It is recommended that regular, long-term postoperative follow-up be undertaken to detect early signs of component wear, infection, instability and to consider the course of action to be taken if such events occur.A suitable rehabilitation program should be designed and implemented.Components should be handled with care to minimize contamination of the component surfaces with any material that would interfere with approximation of the bone cement to the component surfaces.Fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.Infection and deep infection are known risks in any total joint surgery.Upon review, there is no indication of manufacturing or design issues.The most likely cause of the reported event appears to be the results of the patient¿s condition that most likely caused the infection.
Event or Problem Description
As reported, approximately 19 months postop the initial right hip tha, this (b)(6) y/o female patient had a total hip prosthesis removed and revised due to infection.The patient was revised to a competitor¿s components.The device will not be returned for evaluation due to hospital kept the devices.Patient was last known to be in stable condition following the event.

• Brand Name: INTEGRIP CC, CLUSTER 50MM, G1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11454272
• Report Number: 1038671-2021-00102
• Device Sequence Number: 3523912
• Product Code: JDI
• UDI-Device Identifier: 10885862038760
• UDI-Public: 10885862038760
• Combination Product (Y/N): N
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2024
• Device Model Number: INTEGRIP CC, CLUSTER 50MM, G1
• Device Catalogue Number: 186-01-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 118