MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK A/R VAR/VAL 2 SHORT COBALT CHROME; HIP COMPONENT

Model Number PHAC1212

Device Problems Corroded (1131); Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

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 Description

Allegedly, femoral implants removed and acetabular liner exchanged due to complications from metal allergy (per surgeon).

Event Description

Allegedly, femoral implants removed and acetabular liner exchanged due to complications from metal allergy (per surgeon).Mrn: 5005249960.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® NECK A/R VAR/VAL 2 SHORT COBALT CHROME
• Type of Device: 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: 12219858
• MDR Text Key: 263367910
• Report Number: 3010536692-2021-00406
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684PHAC12121
• UDI-Public: M684PHAC12121
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHAC1212
• Device Catalogue Number: PHAC1212
• Device Lot Number: 1537309
• 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
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female