MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD 54/28MM BH DUAL MOBILITY INSERT; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/POLYMER,POROUSUNCEMENTED

Model Number 74121654

Device Problems Unintended Movement (3026); Patient Device Interaction Problem (4001)

Patient Problem Injury (2348)

Event Date 10/25/2019

Event Type  Injury  

Event Description

It was reported that the patient underwent a closed reduction due to dislocation on (b)(6) 2019.The cup was retained and the unknown ceramic head was involved.The stem was from a competitor device.

Manufacturer Narrative

It was reported that the patient underwent a closed reduction due to dislocation.The implanted devices, were all used in treatment.Additional information have been requested for this complaint but have not become available.No lot numbers were provided; hence documentation review could not be completed.If more information is received, this investigation will be reopened.Without the details of the devices involved in this complaint, a specific risk management review for the devices cannot be performed.If this information becomes available at a later time, the task will be reopened and completed.The available medical documents were reviewed.The manual manipulation of the hip as well as the hip instability due to his previous anterior and posterior operative approaches cannot be ruled out as contributing factors to his acute dislocation.The dislocation is not associated with a malperformance of the implant.The patient impact beyond the closed reduction cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: 54/28MM BH DUAL MOBILITY INSERT
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/POLYMER,POROUSUNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 10269948
• MDR Text Key: 198685514
• Report Number: 3005975929-2020-00248
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00885556577264
• UDI-Public: 00885556577264
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

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 Model Number: 74121654
• Device Catalogue Number: 74121654
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention