MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 32 + 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 71303208

Device Problem Packaging Problem (3007)

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

Event Date 11/25/2020

Event Type  malfunction  

Event Description

It was reported that, during surgery, while opening the packaging of the femoral head, it got stuck to the piece itself.It was not possible to eliminate the entire plastic package attached to the product and procedure was concluded with a back-up device from smith and nephew and with a delay greater than 30 minutes.

Manufacturer Narrative

H3, h6: the associated device packaging, used in treatment, was returned and evaluated.A visual inspection of the returned device packaging could not confirm the stated failure mode.Only the opened inner sterile tray and a chart-stick ware returned for evaluation.A review of 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The probable cause for this event is likely inadequate packaging material.This failure mode has been previously identified.Since the manufacturing of the complaint device, a design change was implemented to eliminate/reduce the occurrence of this failure.Based on this investigation, the need for corrective action is not indicated.Should 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: COCR 12/14 FEM HEAD 32 + 8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11010836
• MDR Text Key: 221736756
• Report Number: 1020279-2020-07443
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 03596010194206
• UDI-Public: 03596010194206
• Combination Product (y/n): N
• PMA/PMN Number: K963509
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71303208
• Device Catalogue Number: 71303208
• Device Lot Number: 15LT61780
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1