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

Model Number	26010008
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/04/2016
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
Sae# (b)(4).Allegedly, the patient started having lt hip pain 3 weeks after surgery.Multiple attempts to relief the pain with corticosteroid injections intra-articular with no success.The patient underwent a surgical intervention for release of the psoas tendon on (b)(6) 2018.The pain and weakness in the left thigh is still persistent.Additional information from clinical received on 26/10/2021 confirming that components were not revised.

• Brand Name: COCR FEMORAL HEAD 32MM SLT TAPER MEDIUM 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: 13178641
• Report Number: 3010536692-2021-00551
• Device Sequence Number: 5983675
• Product Code: LPH
• UDI-Device Identifier: M684260100081
• UDI-Public: M684260100081
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K002149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2022

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: 26010008
• Device Catalogue Number: 26010008
• Device Lot Number: 1487964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 10/21/2021; 10/21/2021
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/06/2022; 12/14/2022
• 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 Sex: Male