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

Model Number	71324040
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PROSTHESISHIPHEMIFEMORALMETALPOLYMERCEMENTEDORUNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9951743
• Report Number: 1020279-2020-01262
• Device Sequence Number: 16962064
• Product Code: KWY
• UDI-Device Identifier: 03596010494313
• UDI-Public: 03596010494313
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/11/2020
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR