MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. SLR BIPOLAR SHELL 41MM OD; HIP COMPONENT

Model Number 17000041

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, after opening the carton for the femoral head (ref: (b)(4), lot:1815693), the sterile packaging for ref: (b)(4), lot:1815693 was found.After opening the sterile packaging, the bipolar shell (17000041, lot 1777440) was contained within the sterile packaging labeled as the femoral head.The surgery was completed, but was delayed by an hour.

• Brand Name: SLR BIPOLAR SHELL 41MM OD
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 13152217
• MDR Text Key: 285149930
• Report Number: 3010536692-2022-00001
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: M684170000411
• UDI-Public: M684170000411
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K861566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 17000041
• Device Catalogue Number: 17000041
• Device Lot Number: 1777440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/17/2021
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention