MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® MODULAR FEMORAL NECK; HIP COMPONENT

Model Number	PHA01202
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
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, a patient was revised due to dislocation.Components not revised: product name: profemur(r) proximal body part id: ppw39102.Product name: profemur(r) roughened distal stem, tapered part id: ppw38026.
Additional Manufacturer Narrative
Additional information received on 09/02/2021, from initial reporter (b)(6).Site stated they used a non-mpo femoral head.Therefore, the incident (b)(4) with part name femoral head biolox delta ceramic 12/14 - 36 s and part id: pha04414, needs to be voided.
Additional Manufacturer Narrative
Due to additional information received on 09/02/2021 from initial reporter ; the following updates and changes have been done for this report: a) the medical device for this event has been replaced by pha01202 profemur® modular femoral neck family, lot no: 1414745; instead of pha04414 femoral head biolox delta ceramic 12/14 - 36 s.B) the medical device pha04414 femoral head biolox delta ceramic 12/14 - 36 s it's not longer attributed to this event.C) a new updated event description has been added for this report.
Event or Problem Description
Allegedly, a patient was revised for dislocation.The patient was implanted with a non-mpo shell, liner, and femoral head.Components not revised: product name: profemur(r) proximal body part id: ppw39102.Product name: profemur(r) roughened distal stem, tapered part id: ppw38026.Additional information received on 09/02/2021, from initial reporter (b)(6).Site stated they used a non-mpo femoral head.Therefore, the incident with part name femoral head biolox delta ceramic 12/14 - 36 s and part id: pha04414, needs to be voided.

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• 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: 12430956
• Report Number: 3010536692-2021-00502
• Device Sequence Number: 11936802
• Product Code: LWJ
• UDI-Device Identifier: M684PHA044141
• UDI-Public: M684PHA044141
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2012
• 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,Followup
• Report Date (Section B): 11/22/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PHA01202
• Device Catalogue Number: PHA01202
• Device Lot Number: 1414745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021; 09/02/2021
• Initial Report FDA Received Date: 09/06/2021
• Supplement Report FDA Received Date: 10/01/2021; 11/22/2021
• 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 Sex: Unknown