MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER MEDIUM; HIP COMPONENT

Model Number	26000026
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
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 underwent total hip replacement.After four years, the poly liner disengaged which caused the patient to undergo revision surgery.On revision it was noted eccentric west of poly which suggests poly was never engaged in shell.Patient 4 weeks ago complained of a pain which in review post op suggests liner fully out.(b)(4).
Additional Manufacturer Narrative
Please void all reports for medwatch.There is no alleged deficiency against this product.This incident is a non-reportable incident and was reported by mistake.This report should be voided.- attachment: [19120064usaccidentalreportmemo.Pdf].

• Brand Name: COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER MEDIUM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9560325
• Report Number: 3010536692-2020-00026
• Device Sequence Number: 2340997
• Product Code: JDL
• UDI-Device Identifier: M684260000261
• UDI-Public: M684260000261
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K004043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: 26000026
• Device Catalogue Number: 26000026
• Device Lot Number: 1607570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/15/2019
• Initial Date Received by Manufacturer: 12/15/2019
• Supplement Date Received by Manufacturer: 12/15/2019
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR