MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION PMI STEM EXTRACTOR TIP

Model Number 9106-5302

Device Problem Break (1069)

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

Event Date 03/25/2020

Event Type  malfunction  

Event Description

Patient underwent total hip arthroplasty on (b)(6) 2020.After the surgery the stem extractor tip was noted to be broken.Patient x-ray was negative.Fda safety report id # (b)(4).

• Brand Name: PMI STEM EXTRACTOR TIP
• Type of Device: EXTRACTOR
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION
• MDR Report Key: 9915549
• MDR Text Key: 186301034
• Report Number: MW5094010
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/30/2020

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: 9106-5302
• Device Catalogue Number: 9106-5302
• Device Lot Number: T16H041E1R2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2020
• 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 Outcome(s): Other
• Patient Age: 82 YR