MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. SLR BIPOLAR INSERT 41-44MM X 28MM ID; HIP COMPONENT

Model Number 17002802

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2023

Event Type  Injury  

Event Description

Allegedly, patient came in for routine post-op examination on (b)(6) 2023.X-rays were taken and it was found that the patient's glenosphere had completely dislocated from the liner.No discomfort or loss of utility was reported and no incident was identified which could have caused the dislocation.The liner was replaced with a new slr liner on (b)(6) 2023.(b)(4).

Manufacturer Narrative

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

• Brand Name: SLR BIPOLAR INSERT 41-44MM X 28MM ID
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 17676585
• MDR Text Key: 322613216
• Report Number: 3010536692-2023-00158
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: M684170028021
• UDI-Public: M684170028021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K861566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 17002802
• Device Catalogue Number: 17002802
• Device Lot Number: 1908771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 09/04/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 11/10/2023
• 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
• Patient Age: 45 YR
• Patient Sex: Male