MAUDE Adverse Event Report: ORTHO DEVELOPMENT CORP. FEMORAL HEAD TRIAL; PROSTHESIS, HIP

Model Number 12/14 FEMORAL HEAD TRIAL 36-6

Device Problems Break (1069); Component Missing (2306)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/05/2020

Event Type  malfunction  

Event Description

During left total hip replacement, surgeon noticed the plastic inside the femoral head trial broke as he found a little piece of plastic.He gave everything to the scrub tech and asked to look if he got all the missing pieces.The scrub tech compared the broken head trial with the other head trials and it appears that there is still missing piece(s).Surgeon looked inside the wound but unable to locate the missing piece(s).After surgery, he looked inside the suction filter and he didn't find anything.Assumed plastic piece is retained in patient.

• Brand Name: FEMORAL HEAD TRIAL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ORTHO DEVELOPMENT CORP.; 12187 south business park drive; draper UT 84020
• MDR Report Key: 10239018
• MDR Text Key: 197766742
• Report Number: 10239018
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12/14 FEMORAL HEAD TRIAL 36-6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other