MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 12/14 TRIAL HEADS TRAY; PROST, KNEE, PAT/FEMTIB, SEMI-CONST, UNCEMENT, POROUS, COATED, POLY/MET/POLY

Model Number	71360351
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thr procedure, the trial head 32 was lost in the patient.So they had to do another operation to get the head out.This caused a delay of greater than 2 hours.
Additional Manufacturer Narrative
D4 part unknown.It was reported that during a total hip replacement procedure, the trial head 32 was lost in the patient.So they had to do another operation to get the head out.This caused a delay of greater than 2 hours.The affected trial head, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.No further medical assessment can be performed at this time.As stated, the cause of the reported event is noted as the surgeon lost the device inside the patient.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: 12/14 TRIAL HEADS TRAY
• Common Device Name: PROST, KNEE, PAT/FEMTIB, SEMI-CONST, UNCEMENT, POROUS, COATED, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9533499
• Report Number: 1020279-2019-04702
• Device Sequence Number: 2460880
• Product Code: MBH
• UDI-Device Identifier: 00885556095065
• UDI-Public: 00885556095065
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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: Health Professional
• Device Model Number: 71360351
• Device Catalogue Number: 71360351
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention