MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFL CER CUP FSO 5 HA SZ 60MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71928110

Device Problem Noise, Audible (3273)

Patient Problem Failure of Implant (1924)

Event Date 06/11/2021

Event Type  Injury  

Event Description

It was reported that, after a thr surgery had been performed on (b)(6) 2013, with a 60mm reflection fso5 shell, biolox forte ceramic liner 36mm 44g, anthology 8ho and biolox forte 36+0 head, a the patient experienced a squeaking hip and a worn and fractured ceramic liner.A revision thr surgery was performed on (b)(6) 2021, in order to address this problem.The shell, liner and head were explanted and replaced with smith and nephew backup devices.Current health status of patient is unknown.

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, patient underwent revision tha for squeaking with ¿worn/fractured ceramic liner¿ approximately 8 years post implantation.It was communicated that the requested clinical documentation and/or explants were not available for inclusion in the medical investigation.Additionally, correspondence reported ¿cannot confirm but likely¿ that all the liner pieces were removed.Without the requested documentation, the clinical root cause of the reported event could not be fully evaluated.Based on the information provided, the squeaking was most likely secondary to the ¿worn/fractured ceramic liner¿; however, the root cause of the fractured liner could not be concluded.The patient impact beyond the reported squeaking, worn/fractured liner, and subsequent revision could not be determined.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 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.Some potential probable causes for this event could include but are not limited to traumatic injury, friction, abnormal loading of limb, excessive forces applied to implant or wear.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: REFL CER CUP FSO 5 HA SZ 60MM
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12060515
• MDR Text Key: 258130191
• Report Number: 1020279-2021-05432
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010540577
• UDI-Public: 3596010540577
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2018
• Device Catalogue Number: 71928110
• Device Lot Number: 08CM06163A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention