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

Device Problems Device-Device Incompatibility (2919); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 274997046
• Report Number: 1038671-2021-00513
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862549341
• UDI-Public: 10885862549341
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1