MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +8; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	71343208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr had been performed on (b)(6) 2017, the patient experimented multiple dislocations recently.This adverse event was addressed through revision surgery to exchange liner and head.Given that the size of r3 cup is 50 mm and, therefore, not able to take a constrained liner, it the r3 cup was also removed.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, smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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: OXINIUM FEM HD 12/14 32MM +8
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11722118
• Report Number: 1020279-2021-03419
• Device Sequence Number: 3765250
• Product Code: LZO
• UDI-Device Identifier: 03596010474230
• UDI-Public: 03596010474230
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 71343208
• Device Catalogue Number: 71343208
• Device Lot Number: 17DM02062
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 04/25/2021
• Supplement Report FDA Received Date: 09/20/2021
• 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