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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.Concomitant medical products: nv gxl liner neutral, 32mm id group 1 cups (cat# 130-32-51 / serial# (b)(4)).Bone screw 6.5mm dia x 20mm long (cat# 120-65-20 / serial# (b)(4)).Bone screw 6.5mm dia x 20mm long (cat# 120-65-20 / serial# (b)(4)).
Event or Problem Description
As reported, approximately 7 years postop the initial right tha, the (b)(6) y/o female patient was having her right femoral head and poly exchanged.The patient was having groin pain.The hip was dislocated, and the femoral head was removed.The stem was checked and found to be well fixed.Attention was turned to the acetabular component.During attempted removal of the poly liner, the cup was found to be loose and was removed.The patient received a new cup, a new extended coverage liner, and femoral head with a +7 sleeve.A 15-30-minute delay was caused; however, the patient did not experience any adverse events as a result of the surgical delay/prolongation.The patient was last known to be in stable condition following the event.The devices will be returned for evaluation.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
After further review of additional information received.(h3) the evaluation noted that revision reported was likely the result of an insufficient bond between the acetabular cup and the bone, which led to aseptic (non-infected) acetabular cup loosening.The most probable root cause associated with the reported event of "loosening - acetabular" is associated with weakened integration of the acetabular component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported, approximately 79 months postop the initial right tha, the patient was underwent a revision procedure to address pain.Revision surgery operative notes were provided.The patient was last known to be in stable condition following the event.The devices will be returned for evaluation.No further issues or complications were reported.No additional information is available.

• 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
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 11374543
• Report Number: 1038671-2021-00075
• Device Sequence Number: 11447456
• 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: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: INTEGRIP CC, CLUSTER 50MM, G1
• Device Catalogue Number: 186-01-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 05/11/2021; 03/24/2025
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 05/18/2021; 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2011
• 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: Disability; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 103 KG