MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 40OD 22ID; PROSTHESISHIPHEMIFEMORALMETALPOLYMERCEMENTEDORUNCEMENTED

Model Number 71324040

Device Problem Fitting Problem (2183)

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

Event Date 12/27/2019

Event Type  malfunction  

Event Description

It was reported that during a surgery, after the prosthesis was installed, it was found that the clasp fell off.After repeated installation and replace, the clasp still fell off.Finally a bigger size bipolar was used to complete the surgery.It is unknown if there was a delay.No injury reported.

• Brand Name: TANDEM INTL BIPOLAR 40OD 22ID
• Type of Device: PROSTHESISHIPHEMIFEMORALMETALPOLYMERCEMENTEDORUNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9951743
• MDR Text Key: 187514347
• Report Number: 1020279-2020-01262
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010494313
• UDI-Public: 03596010494313
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

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: 71324040
• Device Catalogue Number: 71324040
• Device Lot Number: 17EM20787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/11/2020
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR