MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR FEMORAL HEAD 32MM SLT TAPER SHORT NECK; HIP COMPONENT

Model Number	26010007
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to dislocation/subluxation.Revision njr number: (b)(4).Side:r.Primary asa: p3 - incapacitating systemic disease.Components not revised: profemur tl classic fixed neck size 6 prtls026 1892400.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.This patient was indicated to have been revised approximately 2 days after the primary operation due to dislocation/subluxation, which is used by the uk njr to capture both dislocation and/or subluxation indications for revision.The revised products were not returned for investigation.No radiographs or operative notes were provided to confirm the complaint for dislocation/subluxation.Review of the device history record (dhr) for this lot indicates that these products were manufactured to specification.Review of historical complaint data reveals no other reported complaints for these lots.Dislocation and subluxation are known risk of total hip arthroplasty and can be influenced by both patient and/or surgical factors.The microport hip systems package insert (150803-8) lists "dislocation, migration and/or subluxation of prosthetic components from improper positioning, trauma, loss of fixation and/or muscle and fibrous tissue laxity" as possible adverse effects of total hip arthroplasty.There were no trends identified for the described complications.This issue will continue to be monitored through complaint tracking.

• Brand Name: COCR FEMORAL HEAD 32MM SLT TAPER SHORT 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: 12851161
• Report Number: 3010536692-2021-00564
• Device Sequence Number: 14476519
• Product Code: LPH
• UDI-Device Identifier: M684260100071
• UDI-Public: M684260100071
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K002149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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: Health Professional
• Device Model Number: 26010007
• Device Catalogue Number: 26010007
• Device Lot Number: 1882480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 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