MAUDE Adverse Event Report: EXACTECH, INC. INTEGRIP CC; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	186-01-54
Medical Device Problem Codes	Loss of Osseointegration (2408); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative- additional information/d4, d1, d10, g4 510k, h4.D10.Concomitant products: 130-32-52 - nv gxl linr, ntrl, 32mm id, group 2 cups sn (b)(6), 120-65-25 - bone screw 6.5mm dia x 25mm long sn (b)(6), 162-00-04 - neck preserving stem, std offset plasma sz 4 sn (b)(6), 170-32-93 - biolox delta femoral head 32mm od, -3.5mm sn (b)(6).There is no additional information available.
Additional Manufacturer Narrative
Liner reported in mfr # 1038671-2023-01518.H3.Investigation results-the revision reported may have been the result of prosthesis wear and acetabular cup loosening as reported in the operative notes.The aseptic (non-infected) acetabular loosening may have been the result of an insufficient bond between the acetabular cup and the bone.Additional contributing factors to the reported failures may have been the result of a combination of the risk factors.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.The sales data for acetabular cup was used to calculate a complaint occurrence rate of (b)(4) for acetabular cup loosening.This is considered ¿very low¿ according to the frequency of occurrence ranking scale detailed below.A review of the risk management report (rmr) was conducted to ensure the risk was included and the occurrence is below the threshold.These devices are used for treatment not diagnosis.There is no additional information available.
Event or Problem Description
It was reported via legal documentation that this patient had and initial right total hip arthroplasty then approximately 7 years, 8 months later they experienced a revision surgical procedure.Revision operative report- postoperative diagnosis: mechanical failure of right total hip with acetabular failure.Indications: loose cup after poly wear.Findings: loose cup.Procedure: capsulotomy was performed revealing a fair amount of fluid, which was sent for cultures.Dislocated the hip and removed the head ball, stem was noted to be intact in good fixation and opted for preservation of stem.¿one screw was removed and cup was removed without difficulty with minimal to the bone.¿ new devices implanted.Dressings applied, then the patient was taken to recovery room without incident.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: INTEGRIP CC
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 19508915
• Report Number: 1038671-2024-01879
• Device Sequence Number: 7424241
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K102975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2022
• Device Catalogue Number: 186-01-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 06/11/2024; 08/12/2026
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 06/11/2024; 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2012
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female