MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M; HIP COMPONENT

Model Number	PHA04416
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Microport was contacted by a patient regarding a possible allergic reaction to the knee replacement.These products had been implanted for approximately 34 months at the time of this complaint.To the knowledge of microport, no revision has yet occurred.Additionally, no clinically relevant documentation is available to confirm this complaint.The microport knee systems package insert (150806-2) lists "allergic reactions to materials; metal sensitivity that may lead to histological reactions" as possible adverse effects of total knee arthroplasty.This issue will continue to be monitored through complaint tracking.(b)(4).
Event or Problem Description
Allegedly, patient had an allergic reaction due to implantation of hip system.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 12438187
• Report Number: 3010536692-2021-00504
• Device Sequence Number: 3714093
• Product Code: LZO
• UDI-Device Identifier: M684PHA044161
• UDI-Public: M684PHA044161
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: PHA04416
• Device Catalogue Number: PHA04416
• Device Lot Number: 1763790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2021
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/28/2021
• Patient Sequence Number: 1