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

Model Number	PRTL0025
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Metal Related Pathology (4530)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem 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 or Problem 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.
Additional 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
• 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: 14380060
• Report Number: 3010536692-2022-00195
• Device Sequence Number: 6725198
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00251
• UDI-Public: M684PRTL00251
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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): 07/29/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 07/29/2022
• 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: 68 YR
• Patient Sex: Male