MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 44OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	71324044
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a hip hemiarthroplasty had been performed, the patient experienced a dislocation.A revision surgery was performed to address the adverse event.The tandem intl bipolar 44od 28id was explanted.The patient outcome is unknown.No additional information provided.
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, a revision surgery was performed approximately 1 week post implantation due a dislocation post-primary tha.Requested operative reports and imaging were not provided for inclusion in the medical investigation; therefore, the root cause could not be fully assessed.The patient impact beyond the dislocation and revision could not be determined as the patient outcome is reportedly unknown.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of 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 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.We consider this investigation closed.

• Brand Name: TANDEM INTL BIPOLAR 44OD 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: 10909242
• Report Number: 1020279-2020-06736
• Device Sequence Number: 3230637
• Product Code: KWY
• UDI-Device Identifier: 03596010494351
• UDI-Public: 03596010494351
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71324044
• Device Catalogue Number: 71324044
• Device Lot Number: R2010870
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 07/07/2021
• 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