MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® R GRIT BLASTED PROX BODY SMALL; HIP COMPONENT

Model Number	PPW39102
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fever (1858); Pain (1994)
Date of Event	04/28/2019
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, on (b)(6) 2019, while in her home sitting in a rest position, patient felt a sudden pain in the hip with associated functional impotence.The following day she was taken to the faggiana orthopedic institute and underwent a visit and radiological examination: the ? prosthetic stem breakage at the proximal third ?.(right leg) patient was therefore forced to undergo a new arthroplasty revision surgery on the right femoral stem with metal osteosynthesis with cerclage on (b)(6) 2019.The operation was followed by a long hospitalization that lasted until (b)(6) 2019 due to the onset of persistent fever.Following her discharge, patient was forced to undergo further hospitalizations for three episodes of dislocation of the right hip prosthesis.Patient has completely lost the ability to walk, if not for short stretches and with the help of a walker and a person to help her.
Event or Problem Description
Allegedly,on (b)(6) 2019, while in her home sitting in a rest position, patient felt a sudden pain in the hip with associated functional impotence.The following day she was taken to the faggiana orthopedic institute and underwent a visit and radiological examination: the ? prosthetic stem breakage at the proximal third ?.(right leg).Patient was therefore forced to undergo a new arthroplasty revision surgery on the right femoral stem with metal osteosynthesis with cerclage on (b)(6) 2019.The operation was followed by a long hospitalization that lasted until (b)(6) 2019 due to the onset of persistent fever.Following her discharge, patient was forced to undergo further hospitalizations for three episodes of dislocation of the right hip prosthesis.Patient has completely lost the ability to walk, if not for short stretches and with the help of a walker and a person to help her.After further review of this event, reliability engineering has been able to determine on (b)(6) 2022 that the cup, liner and head are not mpo products.

• Brand Name: PROFEMUR® R GRIT BLASTED PROX BODY SMALL
• 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: 15052269
• Report Number: 3010536692-2022-00253
• Device Sequence Number: 17339352
• Product Code: LWJ
• UDI-Device Identifier: M684PPW391021
• UDI-Public: M684PPW391021
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K003016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: PPW39102
• Device Catalogue Number: PPW39102
• Device Lot Number: 1654900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 10/11/2022
• 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: 89 YR
• Patient Sex: Unknown