MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PRSTHSS,HP,SM-CNSTRAIND,METAL/METAL, RESURFACING

Model Number 74120156

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 09/02/2011

Event Type  Injury  

Event Description

It was reported that patient had a deep post operative infection (ecoli) and a revision surgery was performed to remove all components.

Manufacturer Narrative

It was reported that the patient had a deep post-operative infection and a revision surgery was performed to remove all components.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.As no device batch numbers were provided for investigation, a manufacturing record review, complaint history review, device labelling / ifu review and risk management review could not be performed.If more information is received, this investigation will be reopened.No medical documents were received.Without the supporting lab results, imaging, medical reports and the analysis of the explanted components, the trunnionosis and metallosis cannot be confirmed and it cannot be concluded that the reported events reactions were associated with a mal-performance of the implant.The patient impact beyond the revision, and expected transient post-op convalescence period 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: ACETLR CUP HAP 56MM W/ IMPTR
• Type of Device: PRSTHSS,HP,SM-CNSTRAIND,METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 10166084
• MDR Text Key: 195524872
• Report Number: 1020279-2020-02474
• 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: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

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: 74120156
• Device Catalogue Number: 74120156
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/19/2020
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 73