MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® PC SHELL 52MM GROUP D; HIP COMPONENT

Model Number	DSPCGD52
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, on tuesday, (b)(6) dr (b)(6) revised an acetabular component from a previous superpath hip, dynasty pc shell.Pt had primary hip on (b)(6) 2020, and later experienced groin pain.Dr reviewed, also had pt receive a second opinion.Not obvious that anything wrong but was thought maybe cup had moved.When we revised their was some micro motion and not obvious signs of bone ingrowth.Was revised to a different companies cup.(b)(4).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: DYNASTY® PC SHELL 52MM GROUP D
• Common Device Name: 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: 14218913
• Report Number: 3010536692-2022-00143
• Device Sequence Number: 14506388
• Product Code: LZO
• UDI-Device Identifier: M684DSPCGD521
• UDI-Public: M684DSPCGD521
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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
• Operator of Device: Other
• Device Model Number: DSPCGD52
• Device Catalogue Number: DSPCGD52
• Device Lot Number: 1845433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male