MAUDE Adverse Event Report: EXACTECH, INC. ALT CUP CLSTR G7 SZ 58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Model Number	ALT CUP CLSTR G7 SZ 58
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, approximately 3 weeks postop the initial right total hip, the (b)(6) y/o male patient was brought back due to an infection.All implants were removed, and the patient received an interspace hip implant.Patient was last known to be in stable condition following the event.The device will be returned for evaluation.Upon review of the available information, there is no evidence that this is a device related problem and no allegation against the device.Implantation of a total joint could result pain, infection, loosening of total joint hardware and the patient should monitor their activity and stresses to the operated limb.The most likely cause of the reported event is patient¿s conditions.Concomitant medical products: alt xle lnr extcov g7 40 (cat# 01-030-42-0740 / serial# (b)(4)).Wedge plasma s/o sz 8 (cat# 188-00-08 / serial# (b)(4)).Biolox delta femoral head 40mm 0d, +3.5mm (cat# 170-40-03 / serial# (b)(4)).
Event or Problem Description
As reported, approximately 3 weeks postop the initial right total hip, the (b)(6) y/o male patient was brought back due to an infection.All implants were removed, and the patient received an interspace hip implant.Patient was last known to be in stable condition following the event.The device will be returned for evaluation.All devices sterile certificates viewed and met requirements for final distribution.

• Brand Name: ALT CUP CLSTR G7 SZ 58
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11580337
• Report Number: 1038671-2021-00133
• Device Sequence Number: 11982312
• Product Code: JDI
• UDI-Device Identifier: 10885862549228
• UDI-Public: 10885862549228
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2021

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 58
• Device Catalogue Number: 01-030-01-0758
• Device Lot Number: 6725733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 60 YR