MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNIPOLAR 48MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

Model Number	126648
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a hemi arthroplasty, and dislocated approx 9 days after surgery.A revision surgery was performed to exchange the tandem uni 12/14 tpr slv + 0 ((b)(4)) and tandem unipolar 48mm ((b)(4)) for a bipolar head size 47.The patient outcome is unknown.
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 revision was performed due to dislocation approximately 9 days post hemi-arthroplasty.Reportedly, the size 48 tandem uni- was revised to a bipolar head size 47.The anz complaint form did not provide insight into the root cause of the reported dislocation and responses to the clinical documentation request has not been received as of the date of this medical investigation.The patient impact beyond the reported early post-op dislocation and subsequent revision procedure could not be determined.The patient outcome is unknown.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of the complaint history did not reveal additional complaints for the listed batch.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 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 UNIPOLAR 48MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12053658
• Report Number: 1020279-2021-05390
• Device Sequence Number: 19708748
• Product Code: LZY
• UDI-Device Identifier: 03596010079770
• UDI-Public: 03596010079770
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K896580
• 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): 08/17/2021

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: 126648
• Device Catalogue Number: 126648
• Device Lot Number: 19DM16437
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/17/2021
• 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; Other; Required Intervention