MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L; HIP COMPONENT

Model Number	PHA04406
Health Effect - Clinical Codes	Paresis (1998); Fluid Discharge (2686)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient's wound is still draining and groin pain in his right hip.Head, neck, liner and dual mobility were swapped out for a new ones.Previous revision captured under the incident group: 20070040.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10339711
• Report Number: 3010536692-2020-00524
• Device Sequence Number: 3065081
• Product Code: LZO
• UDI-Device Identifier: M684PHA044061
• UDI-Public: M684PHA044061
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K140043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: PHA04406
• Device Catalogue Number: PHA04406
• Device Lot Number: 1831533
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR