MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ALUM CER LNR 32ID 56-66; PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED

Catalog Number 71338456

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 03/02/2021

Event Type  Injury  

Event Description

It was reported that after primary surgery, patient complained of pain.Revision surgery was performed, and it was found that the ceramic liner failed and broken in many pieces.The liner ((b)(4)) and head ((b)(4)) were removed from the patient.The shell was kept in place.A competitor cemented liner and s&n oxinium head were used for replacement.Liner and head were unable to obtain due to fragmentation, and the hospital discarded them.The outcome of the patient is unknown.

Manufacturer Narrative

H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports a revision surgery was performed due to pain; it was found intraoperatively that the ceramic liner had broken into several pieces.Per email correspondence, the requested surgical records and x-rays are not available.Without sufficient supporting medical evidence, a clinical assessment cannot be rendered at this time.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A review of complaint history did not reveal additional complaints for the listed device.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.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.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: ALUM CER LNR 32ID 56-66
• Type of Device: PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11573369
• MDR Text Key: 242374589
• Report Number: 1020279-2021-02401
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00885556021453
• UDI-Public: 885556021453
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 71338456
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 07/20/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention