MAUDE Adverse Event Report: EXACTECH, INC. ALT CUP CLSTR G7 SZ 56; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ALT CUP CLSTR G7 SZ 56
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the male patient has had two dislocations.It was decided to revise the cup to a dual mobility system.The patient had previous spinal fusion, including l5-s1 fusion which we believe was causing the dislocations.Patient was last known to be in stable condition following the event.The devices will be returned.Concomitant devices: alt xle lnr extcov g7 40 (cat#: 01-030-42-0740 / serial#: (b)(4)).Biolox delta femoral head 40 mm 0d, +3.5 mm (cat#: 170-40-03 / serial#: (b)(4)).
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2, h3 and h6 have been updated accordingly.(h3) as reported, the male patient has had two dislocations.It was decided to revise the cup to a dual mobility system.The patient had previous spinal fusion, including l5-s1 fusion which we believe was causing the dislocations.Patient was last known to be in stable condition following the event.The devices will be returned.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 the dislocation and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying conditions including the vertebral fusion the patient had.

• Brand Name: ALT CUP CLSTR G7 SZ 56
• 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: 12291543
• Report Number: 1038671-2021-00374
• Device Sequence Number: 3670654
• Product Code: JDI
• UDI-Device Identifier: 10885862549211
• UDI-Public: 10885862549211
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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: ALT CUP CLSTR G7 SZ 56
• Device Catalogue Number: 01-030-01-0756
• 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: 07/19/2021
• Supplement Date Received by Manufacturer: 10/31/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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: 77 YR
• Patient Sex: Male