MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. INTERSEAL® DURAMER® ACETABULAR C-LINER 32MM 15° GR; HIP COMPONENT

Model Number	30153258
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly the poly is worn.Additional information: dislocating on (b)(6) 1998.

• Brand Name: INTERSEAL® DURAMER® ACETABULAR C-LINER 32MM 15° GR
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10083061
• Report Number: 3010536692-2020-00373
• Device Sequence Number: 16337653
• Product Code: KWY
• UDI-Device Identifier: M684301532581
• UDI-Public: M684301532581
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K931333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2020

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: Health Professional
• Device Model Number: 30153258
• Device Catalogue Number: 30153258
• Device Lot Number: 028A01955701
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 05/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention