MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 02/26/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to instability.

Manufacturer Narrative

As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: BHR ACETABULAR CUP 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8411510
• MDR Text Key: 138499748
• Report Number: 3005975929-2019-00126
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2019
• Patient Sequence Number: 1
• Treatment: HEMI HEAD, # 74122550, LOT # UNKNOWN; MODULAR SLEEVE PART# 74222100. LOT UNKNONW; SYNERGY STEM. PART# 71306109S, LOT UNKNOWN; HEMI HEAD, # 74122550, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention