MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PREP IM ENCHANCE TOTAL HIP KIT; CEMENT OBTURATOR

Model Number 121010

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

Smith & nephew, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, inc., or its employees, that the report constitutes an admission that the device, smith & nephew, inc., or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that, during surgery, the flexible green bucks cement on the prep im enchance total hip kit broke while surgeon was inserting the cement restrictors.There was a delay less than 30 minutes because surgeon had to remove the broken piece from the femoral canal.Patient was not harmed.No other complications were reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the responses to clinical information requests were not provided and the s+n device has not been returned to fully evaluate the root cause of the reported events.According to the report, there was a delay less than 30 minutes because surgeon had to remove the broken piece from the femoral canal.Based on the limited information provided.The impact to the patient beyond that which has already been reported could not be determined.Per report, the patient was not harmed, and no other complaints were reported.Therefore, no further clinical/medical assessment is warranted at this time.A review of the complaint history did not reveal additional complaints for the listed batch.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 the risk management file revealed this failure mode was previously identified.This is a single use device, damage from misuse, excessive cleaning or rough handling are likely probable causes of the reported event based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.

• Brand Name: PREP IM ENCHANCE TOTAL HIP KIT
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11850007
• MDR Text Key: 251652010
• Report Number: 1020279-2021-04467
• Device Sequence Number: 1
• Product Code: LZN
• UDI-Device Identifier: 03596010457127
• UDI-Public: 03596010457127
• Combination Product (y/n): N
• PMA/PMN Number: K791125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 121010
• Device Catalogue Number: 121010
• Device Lot Number: 20JSM0060
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention