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

Model Number	INTEGRIP CC, CLUSTER 50MM, G1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: 130-32-51, 3984446 - nv gxl liner neutral, 32mm id group 1 cups; 142-32-93, 3655532 - cocr fem head 32mm -3.5 offset 12/14; 164-03-12, 3983412 - element-stem, collared w/ha, std offset, sz 12; 180-65-20, 4008655 - alteon 6.5mm screw, 20mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 6 yrs postop initial rtha, this 75 y/o male patient is found to have osteolysis and has not been revised at this point.The patient has been referred for possible revision.
Additional Manufacturer Narrative
H3: as reported, approximately 6 yrs postop initial rtha, this 75 y/o male patient is found to have osteolysis and has not been revised at this point.The patient has been referred for possible revision.Unknown review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.This cause of the reported event is most likely patient conditions, however; cannot be confirmed as the device was not returned due to remaining implanted.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12338754
• Report Number: 1038671-2021-00395
• Device Sequence Number: 4542030
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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 Model Number: INTEGRIP CC, CLUSTER 50MM, G1
• 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: 07/29/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 11/22/2021
• 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: 74 YR
• Patient Sex: Male