MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MEMPHIS RECON HIP INSTR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/15/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case(b)(4).

Event Description

It was reported that after a thr surgery was performed on (b)(6) 2022 using a customized hip calibration gauge, it was discovered on the post op x-ray, that the socket screw device was not removed prior to wound closure.Due to this, a revision surgery had to be performed on (b)(6) 2022, in order to remove it.There were no symptoms prior to the x-rays confirmation.Patient current health status is unknown.No further information is available.

Manufacturer Narrative

Additional information received by the reporter has identified that this event should be re-evaluated for mdr reporting.The new information states that smith and nephew is the distributor of the device, and the legal manufacturer for this device is enztec, will review the event and determine reportability.They will report to the food and drug administration and any other authorities as deemed necessary, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: MEMPHIS RECON HIP INSTR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16134853
• MDR Text Key: 307060871
• Report Number: 1020279-2023-00068
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention