MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH+NEPHEW DEV; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71325044

Device Problem Unclear Information (4052)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/13/2020

Event Type  Injury  

Event Description

It was reported that during surgery, a foreign matter colored green was found in the patient during surgery.There was not devices colored green therefore the doctor did not concern about it.There were 2 possibilities it was a part of the nurse's glove or, a part of a sticker of a smith and nephew device.The hospital requires investigation of the matter.There was no surgical delay and no injuries to the patient.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation but the pictures were reviewed and the failure mode was confirmed, green foreign matter was found.The clinical/medical investigation concluded that, it was communicated that there was 2 possible contributors to the green-colored foreign body retrieved from the patient, ¿the foreign body most likely originated from either the green gloves or the green sticker from the outside of the metallic instrument box¿; however, the root cause could not be definitively concluded based on the images provided.Imaging appeared to show a small (~1mm), deformed green fragment of unknown origin/material and those from the microscopic exam performed by the customer appear to show a mottled/roughened surface which could be consistent with a glove-type material, but this could not be confirmed.Reportedly, there was no surgical delay or patient injury/harm and the ¿doctor did not concern about it¿; therefore, further patient impact is not anticipated and no further medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to environmental contamination.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: SMITH+NEPHEW DEV
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10143504
• MDR Text Key: 194803711
• Report Number: 1020279-2020-02322
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 71325044
• Device Lot Number: 19BM02999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention