MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. REF THREE HOLE SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71336454

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/21/2018

Event Type  malfunction  

Event Description

It was reported that the doctor implanted the ref cup during the operation then opened the insert while it couldn't get into the cup.Under the condition that the product code was consistent with the outer cup, it was always not in place.The staff temporarily took a new set of products, but it was still can not be implanted.The doctor tried to take the product out of the body, and the insert and the cup were not in place outside the body.Finally a new outer cup was opened and the insert was rigidly implanted.

Manufacturer Narrative

The three hole shell was returned and evaluated.A visual inspection found light damage from attempted use on the device.The device was functionally checked and was found to work as intended.A review of the complaint history for the associated batch did not reveal additional complaints.Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: REF THREE HOLE SHELL 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0110148276
• MDR Report Key: 7859888
• MDR Text Key: 119821082
• Report Number: 1020279-2018-01763
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010454362
• UDI-Public: 03596010454362
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K960094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71336454
• Device Lot Number: 15AM13113
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 70