MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® Z STEM PLASMA SPRAYED; HIP COMPONENT

Model Number	PHA00264
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Microport post market quality was made aware of this revision through a microport distributor.Per the provided incident report, the surgeon indicated that this patient was revised due to a "metal allergy." the length of implantation is unknown.Descriptions of the femoral components were provided, but no specific item numbers or lots are known.The revised products have not been returned to microport for investigation.No images, operative notes, or other clinically relevant documentation has been provided to confirm the complaint.The microport hip systems package insert (150803-8) lists "allergic reactions to materials; metal sensitivity; or reactions to wear debris that may lead to histological reactions, pseudotumor and aseptic lymphocytic vasculitis-associated lesions (alval)" as possible adverse effects of total hip arthroplasty.There were no trends identified per mpo trending procedures.No conclusions can be made from the available information.This issue will continue to be monitored through complaint tracking.
Event or Problem Description
Allegedly, femoral implants removed and acetabular liner exchanged due to complications from metal allergy (per surgeon).
Event or Problem Description
Allegedly, femoral implants removed and acetabular liner exchanged due to complications from metal allergy (per surgeon).Mrn: (b)(4).Additional information received on april 11,2022: allegedly, on or about (b)(6) 2021, patient reported for revision surgery of her failed left hip prosthesis.It was recommended a revision surgery after patient presented with pain and lack of mobility.Revision surgery was necessary because the device failed due to corrosion at the neck-stem junction of the device.On or about (b)(6) 2021, it was discovered that the left-sided device failed due to corrosion of the oblong taper of the profemur cocr modular neck where it seated in the pocket of the profemur titanium stem, which caused physical injury to patient.

• Brand Name: PROFEMUR® Z STEM PLASMA SPRAYED
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 12219759
• Report Number: 3010536692-2021-00405
• Device Sequence Number: 5127958
• Product Code: LZO
• UDI-Device Identifier: M684PHA002641
• UDI-Public: M684PHA002641
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• 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): 07/12/2022
• 2 Devices were Involved in the Event: 1 2

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: PHA00264
• Device Catalogue Number: PHA00264
• Device Lot Number: 1548962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female