MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S CLR STD SZ 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ALT HA S CLR STD SZ 3
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/24/2022
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 / (b)(4)); biolox delta femoral head 32mm od, +0mm (cat# 170-32-00 / (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately four years post initial left tha, this (b)(6) female patient was brought back for left hip pain due to a loose stem.The hip was dislocated, the femoral head was removed, attention turned to the cup, the liner was removed with the help of an osteotome, the cup was checked and found to be well fixed.A new xle g1 lipped liner was implanted.The stem was checked, found to be loose and removed.A new stem and head was then implanted.Patient was revised to xle g1 32mm lipped insert, a std 7 taper wedge stem and a 32++0 biolox head.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.The device will be return.
Additional Manufacturer Narrative
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 3
• 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: 14117992
• Report Number: 1038671-2022-00416
• Device Sequence Number: 2291657
• Product Code: JDI
• UDI-Device Identifier: 10885862321053
• UDI-Public: 10885862321053
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: 10/19/2022
• Device Model Number: ALT HA S CLR STD SZ 3
• Device Catalogue Number: 190-30-03
• 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: 03/27/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2017
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female