MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® TL STEM SZ 5; HIP COMPONENT

Model Number PRTL0025

Device Problem Material Discolored (1170)

Patient Problems Unspecified Infection (1930); Pain (1994); Metal Related Pathology (4530)

Event Date 04/13/2022

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, the patient has been suffering moderate pain, and the implants were revised for metallosis, according to the surgeon.The modular neck trunion (fitting in to the stem pocket) was noticeably "blackened".All implants were removed, and replaced with a thr cement spacer.Unfortunately it wasn't possible to remove the liner from the procotyl l shell, so i cant provide the lot number for the biolox liner.

Event Description

Allegedly, the patient has been suffering moderate pain, and the implants were revised for metallosis, according to the surgeon.The modular neck trunion (fitting in to the stem pocket) was noticeably "blackened".All implants were removed, and replaced with a thr cement spacer.Unfortunately it wasn't possible to remove the liner from the procotyl l shell, so i cant provide the lot number for the biolox liner.Additional information received on 05/13/2022 from njr: njr advised that the patient was reviewed due to infection and adverse soft tissue reaction to particulate debris.Revision njr number: (b)(4).Site: r.Primary asa: p2 - mild disease not incapacitating.

Manufacturer Narrative

Section b.5:additional information in description / section f.6: awareness date update / section h.6 health code (1930) added.

• Brand Name: PROFEMUR® TL STEM SZ 5
• 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: 14380060
• MDR Text Key: 291597541
• Report Number: 3010536692-2022-00195
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00251
• UDI-Public: M684PRTL00251
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

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
• Device Operator: Other
• Device Model Number: PRTL0025
• Device Catalogue Number: PRTL0025
• Device Lot Number: 1746041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2022
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 07/29/2022
• 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: 68 YR
• Patient Sex: Male