MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 22 + 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 71302200

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2020

Event Type  malfunction  

Event Description

It was reported that during surgery, a 22mm and zero head was about to be implanted but surgeon noted that the head looked very big for a 22mm.When the staff checked the inside of the implant, noted that it was a 28mm minus 3 and not the size as per packaging.The nurse confirmed that the box was sealed.There was a delay of less than thirty minutes and procedure was concluded with a backup device.No injury reported.

Manufacturer Narrative

The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.A quality hold was placed in an attempt to quarantine and re-inspect additional product for this failure mode.This issue has been submitted to our capa process in accordance with applicable internal capa procedures.This issue has been elevated to our risk assessment process to determine if any additional actions are needed.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.

• Brand Name: COCR 12/14 FEM HD 22 + 0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9951232
• MDR Text Key: 187514864
• Report Number: 1020279-2020-01261
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 03596010194039
• UDI-Public: 03596010194039
• 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: 06/10/2020

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: 71302200
• Device Catalogue Number: 71302200
• Device Lot Number: 19EM18405
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/11/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR