MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120156

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

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

Event Date 11/20/2019

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to low grade infection.

Manufacturer Narrative

It was reported that a right hip revision surgery was performed.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.A review of the complaint history for the cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup.Without definitive part/lot numbers for the head/ sleeve/ stem a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part number for a 74222100 modular sleeve -4mm 12/14 & 74222150 bhr modular head 50mm in search of complaints involving infection throughout the lifetime of the product.Similar complaints have been identified and this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.Review of the product ifu for the cup found adequate warnings and pre-cautions in relation to the alleged failure modes.Without the details of the devices involved in this complaint, the specific product labelling and ifu's for the head / sleeve / stem cannot be reviewed.If this information becomes available at a later time, the task will be reopened and completed.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.No medical documents were received.It was communicated that consent has not been granted for the patient¿s clinical/medical records to be released and included in this assessment.Therefore, a clinical assessment cannot be performed and the patient impact beyond the revision surgery cannot be concluded.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 re-opened.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: 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: 9457164
• MDR Text Key: 170426157
• Report Number: 3005975929-2019-00429
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/28/2013
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Device Lot Number: 83647
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74222100 MODULAR SLEEVE -4MM 12/14; 74222150 BHR MODULAR HEAD 50MM; HEAD 50MM UNKNOWN PART AND LOT NUMBER; SLEEVE UNKNOWN PART AND LOT NUMBER; UNKN01102100 UNKN BHR IMPLANT; HEAD 50MM UNKNOWN PART AND LOT NUMBER; SLEEVE UNKNOWN PART AND LOT NUMBER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR