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

Model Number	INTEGRIP CC, CLUSTER 58MM, G3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: novation gxl lnr +5 lat 40mm group 3 cups (cat# 136-40-53 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 14 months postop the initial ltha, the (b)(6) male patient had a revision of an exactech hip, liner and cup, due to patient complaining of pain at site.Patient was revised to a zimmer tm cup and trilogy liner.Patient was last known to be in stable condition following the event.The devices are not available for evaluation, due to facility policy.
Additional Manufacturer Narrative
Section h10: (h3) upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is unknown at this time however is most likely patient conditions.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12741234
• Report Number: 1038671-2021-00573
• Device Sequence Number: 14484965
• Product Code: JDI
• UDI-Device Identifier: 10885862038807
• UDI-Public: 10885862038807
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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 Model Number: INTEGRIP CC, CLUSTER 58MM, G3
• Device Catalogue Number: 186-01-58
• 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: 10/13/2021
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male