MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFL CER CUP FSO 5 HA SZ 60MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71928110

Device Problem Break (1069)

Patient Problem Joint Dislocation (2374)

Event Date 03/23/2021

Event Type  Injury  

Event Description

It was reported that a revision surgery had to be performed because the patient had a dislocated hip.The reflection ceramic cup was shattered.Ceramic cup.The patient had has an asr revision surgery.It is unknown if the surgery was successfully completed and the patient current health status.

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 surgery was performed due to a dislocated hip in a patient with a prior revision.Reportedly, the reflection ceramic liner had shattered and also required revision along with the cup, liner, and head (sleeve insert).It was communicated that the requested clinical information is not available; however, the patient was ¿home¿.Based on the limited information provided, the root cause of the reported dislocation and liner fracture could not be fully assessed.Patient impact beyond the reported events 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 the 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 are not limited to traumatic injury, abnormal loading of limb or excessive forces applied to implant.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: REFL CER CUP FSO 5 HA SZ 60MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11685234
• MDR Text Key: 246012898
• Report Number: 1020279-2021-03180
• Device Sequence Number: 1
• Product Code: JDH
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71928110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention