MAUDE Adverse Event Report: BIOPRO, INC BIOPRO PSL HIP STEM

Model Number	17043
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On 6/25/2020 biopro was notified of a failed extra short hip stem.The stem was implanted on (b)(6) 2009.An additional phone call was held with the surgeon on 6/29/2020 to gather more information.The patient was experiencing pain for quite a while, but was walking.When she explained the pain an x-ray was performed and the fracture of the hip stem was evident.She indicated that 2 years previously she had suffered a fall.Upon review of an x-ray taken in 2019 a hair line fracture in the hip stem was evident, but not noted at the time of the x-ray.It is unknown when the hip stem failed, but remodeling of the bone around the distal end of the implant is indicative of the implant moving within the bone for an extended period of time.Additionally, when this hip was implanted in 2009 the surgeon utilized a technique which resulted in the hip stem remaining somewhat more proximal, the surgeon has since modified his implant technique.The hip will be removed and will be examined when it is returned.

• Brand Name: BIOPRO PSL HIP STEM
• Common Device Name: HIP STEM
• Manufacturer (Section D): BIOPRO, INC; 2929 lapeer road; port huron MI 48060
• MDR Report Key: 10214464
• Report Number: 1832656-2020-00004
• Device Sequence Number: 3232857
• Product Code: LPH
• UDI-Device Identifier: M209170430
• UDI-Public: M209170430
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K922500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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: No Information
• Device Model Number: 17043
• Device Catalogue Number: 17043
• Device Lot Number: 106473
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR