MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ACETABULAR REAMER 57MM HEX; HIP INSTRUMENT

Model Number	SPTHRM57
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Allegedly there is oxidation/rusty on the reamer surface, especially close to the laser marking.Surgery was extended greater than 30 minutes.Kit number: sprmkit1.Kit lot number: g161553.

• Brand Name: ACETABULAR REAMER 57MM HEX
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8903129
• Report Number: 3010536692-2019-01007
• Device Sequence Number: 2206795
• Product Code: HWE
• UDI-Device Identifier: M684SPTHRM571
• UDI-Public: M684SPTHRM571
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2019

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: SPTHRM57
• Device Catalogue Number: SPTHRM57
• Device Lot Number: 1325944
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention