MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 46OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	71324046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a hip hemiarthroplasty had been performed with a tandem system on (b)(6) 2021 to treat a femur fracture, the patient suffered from a hip dislocation six days afterwards.It is unknown how this adverse event was addressed and so is the patient current status of health.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a patient suffered a hip dislocation 6 days post-op hip hemiarthroplasty (tandem system to treat a femur fracture).Responses to the requested documentation has not been received as of the date of this medical investigation.Without the requested information, the root cause could not be fully assessed nor concluded.The patient impact beyond the reported dislocation could not be determined.Clarification of translated statement: ¿at the scopic check the prosthesis is disassembled as shown in the image¿ was not received and no image was noted in eqms attachments.No further medical assessment could be rendered at this time.Should clinically relevant documentation become available in the future, this case may be re-opened/re-assessed.A review of the complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.

• Brand Name: TANDEM INTL BIPOLAR 46OD 28ID
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11991459
• Report Number: 1020279-2021-05148
• Device Sequence Number: 13690187
• Product Code: KWY
• UDI-Device Identifier: 03596010494375
• UDI-Public: 03596010494375
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71324046
• Device Catalogue Number: 71324046
• Device Lot Number: R2122650
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention