MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S CLR STD SZ 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Model Number	ALT HA S CLR STD SZ 8
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: biolox delta femoral head 36mm od, +3.5mm (cat# 170-36-03 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 1 yr.Postop the initial r tsa, this (b)(6) patient's right shoulder was revised due to loosening of the femoral stem.Patient was last known to be in stable condition following the event.Device will return due to facility policy.
Additional Manufacturer Narrative
After further review of additional information received the following sections d9, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral stem.The most probable root cause associated with the reported event of "loosening - femoral stem¿ is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: ALT HA S CLR STD SZ 8
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 11586207
• Report Number: 1038671-2021-00137
• Device Sequence Number: 4297514
• Product Code: JDI
• UDI-Device Identifier: 10885862321107
• UDI-Public: 10885862321107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 04/11/2022

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: 05/17/2022
• Device Model Number: ALT HA S CLR STD SZ 8
• Device Catalogue Number: 190-30-08
• 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: 03/10/2021
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2017
• 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: 57 YR
• Patient Sex: Male