MAUDE Adverse Event Report: STRYKER GLOBAL HEADQUARTERS STRYKER TOTAL HIP ARTHROPLASTY; ACETABULAR COMPONENT HIP ARTHROPLASTY

Lot Number SEE NARRATIVE

Device Problems Other (for use when an appropriate device code cannot be identified) (2203); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2017

Event Type  malfunction  

Event Description

Risk received a report that patient had screws retained but when the chart was reviewed found that the surgeon was performing a revision of a right total hip arthroplasty due to preoperative diagnosis of complication involving arthroplasty hardware.On surgeon workup he stated one of the screws accompanying appeared to not be in the bone.Found that the patient had a hip replacement in 2012 and the revision (b)(6) 2017 was being performed due to pain and difficulty with adls.In the operative report the surgeon discussed how the femoral head was removed easily by impacting it with a mallet.The plastic liner was removed without difficulty and the 2 bone screws.The acetabulum was also removed without difficulty.The acetabulum component was removed "with no bone loss suggesting that it might not have been grown in well." the reconstructive surgery was performed.Looking at the old operative record from (b)(6) 2012 it does discuss how there were 2 bone screws used to stabilize the implant.With looking at the chart we do not see any retained foreign body but a device that was concerning for the surgeon.The procedure performed "a revision acetabular component, right hip.".

• Brand Name: STRYKER TOTAL HIP ARTHROPLASTY
• Type of Device: ACETABULAR COMPONENT HIP ARTHROPLASTY
• Manufacturer (Section D): STRYKER GLOBAL HEADQUARTERS; 2825 airview boulevard; kalamazoo MI 49002
• MDR Report Key: 6731241
• MDR Text Key: 80762890
• Report Number: 6731241
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: SEE NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2017
• Distributor Facility Aware Date: 06/21/2017
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR