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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: nv gxl liner neutral, 32mm id group 1 cups (cat# 130-32-51 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately five years post initial right tha, surgeon preformed at rtha and discovered that the novation integrip cc cluster shell in his opinion had not achieved proper fixation.A competitor's cup and liner were used as replacement.However, an exactech chrome cobalt head was used to replace the original head implant.There was no breakage of the device or surgical delay/prolongation.Sales rep was unable to obtain photos/x-rays.The device is not available for evaluation due to the product that was removed was discarded with biohazards material.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of acetabular loosening.The reported acetabular loosening could not be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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: 16843589
• Report Number: 1038671-2023-00869
• Device Sequence Number: 17857675
• Product Code: JDI
• UDI-Device Identifier: 10885862038760
• UDI-Public: 10885862038760
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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 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: 04/08/2023
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2018
• 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: ALT HA S CLR STD SZ 8.; COCR FEM HEAD 32MM +0 OFFSET 12/14.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female