MAUDE Adverse Event Report: EXACTECH, INC. INTEGRIP CC, CLUSTER 56MM,G3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	INTEGRIP CC, CLUSTER 56MM,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	05/26/2022
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).Biolox delta femoral head 40mm 0d, +3.5mm (cat# 170-40-03).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the female patient had a left hip revision of exactech cup.Exactech 36mm +10mm used with existing exactech stem.Patient was revised to a competitor's cup.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays.The device is not available for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, the female patient had a left hip revision of exactech cup.Exactech 36mm +10mm used with existing exactech stem.Patient was revised to a competitor's cup.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays.The device is not available for evaluation.No additional information provided after 3 attempts.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: INTEGRIP CC, CLUSTER 56MM,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: 14750737
• Report Number: 1038671-2022-00695
• Device Sequence Number: 6047198
• Product Code: JDI
• UDI-Device Identifier: 10885862038791
• UDI-Public: 10885862038791
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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 56MM,G3
• Device Catalogue Number: 186-01-56
• 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: 05/31/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 09/23/2022
• 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 Sex: Female