MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR TL STEM SZ 4; HIP COMPONENT

Model Number	PRTL0024
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
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, patient was revised due to periprosthetic fracture stem.Revision njr number: (b)(6).Side:r.Primary asa: p1 - fit and healthy.Components not revised: procotyl l beaded and ha coated cup size 54mm product number: pha06264 lot number: 111.Rim-lock biolox delta ceramic liner 36mm id group e: product number : pha04510 lot number: 111.
Event or Problem Description
Allegedly, patient was revised due to periprosthetic fracture stem.Revision njr number: (b)(4).Side:r.Primary asa: p1 - fit and healthy.Components not revised: procotyl l beaded and ha coated cup size 54mm product number: pha06264 lot number: 118717906.Rim-lock biolox delta ceramic liner 36mm id group e: product number : pha04510 lot number: 069896421.Additional information received on 10/20/2020 from (b)(6): adding lot numbers.Mhra reference no: (b)(4).
Additional Manufacturer Narrative
Additional information was received on 10/20/2020.Updated incident description, and lot number.

• Brand Name: PROFEMUR TL STEM SZ 4
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10648138
• Report Number: 3010536692-2020-00639
• Device Sequence Number: 14353730
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00241
• UDI-Public: M684PRTL00241
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K060358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: PRTL0024
• Device Catalogue Number: PRTL0024
• Device Lot Number: 079876430
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 12/23/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention