MAUDE Adverse Event Report: EXACTECH, INC. ALT CUP MULTI G5 SZ 52; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ALT CUP MULTI G5 SZ 52
Medical Device Problem Codes	Device-Device Incompatibility (2919); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant device: 36mm +10mm femoral head (cat# 100-36-10 / 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 month postop the implantation of this hip, on (b)(6) 2021 the surgeon removed the alteon cup because it never achieved initial fixation.He converted to a dual mobility smith and nephew cup and a new exactech femoral head.It was noted that additional screws helped achieve fixation this time.No additional information available including xrays or explants.Additional information received indicates after first revision related to this case, patient followed up with pain and x-ray revealed the cup had moved and come loose.Surgeon felt he may have needed more than the 2 screws he used with the alteon multi hole cup.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2, h3 and h6 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of an insufficient bond between the implant and the bone during the first revision surgery and/or not using enough bone screws to secure the acetabular cup, which led to aseptic (non-infected) acetabular loosening.However, this cannot be confirmed as the devices were not returned for evaluation and x-rays were not provided.The most probable root cause associated with the reported event of "loosening - acetabular" is associated with weakened integration of the acetabular component 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 CUP MULTI G5 SZ 52
• 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: 12571777
• Report Number: 1038671-2021-00513
• Device Sequence Number: 4112991
• Product Code: JDI
• UDI-Device Identifier: 10885862549341
• UDI-Public: 10885862549341
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ALT CUP MULTI G5 SZ 52
• Device Catalogue Number: 01-030-02-0552
• 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: 09/14/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown