MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 S; HIP COMPONENT

Model Number	PHA04408
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/29/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, wound infection in the patient right hip was detected.The patient had a medical intervention for wound debridement.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 S
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10363106
• Report Number: 3010536692-2020-00551
• Device Sequence Number: 2228704
• Product Code: LZO
• UDI-Device Identifier: M684PHA044081
• UDI-Public: M684PHA044081
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2020

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: PHA04408
• Device Catalogue Number: PHA04408
• Device Lot Number: 1478905
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 72