MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120150

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

Patient Problems Unspecified Infection (1930); Pain (1994); Discomfort (2330); Injury (2348); Reaction (2414)

Event Date 05/19/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery from the left hip was performed due to pain, discomfort, metal-on-metal reaction and infection.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the hemi head and modular sleeve were removed.The bhr cup and stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.Without definitive lot numbers a complete complaint history review cannot be performed for the hemi head involved.A review of the complaint history for the bhr cup and modular sleeve 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 bhr cup.Similar complaints have been identified for the modular sleeve 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.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.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.The available medical documents were reviewed.It should be noted, during the implantation the acetabulum was reamed to a size 50 and a size 50 cup was implanted.Surgical technique indicates sequential reaming to 2mm less than the definitive acetabular component to be inserted.It should also be noted the infection was noted as being secondary to pneumonia and is not associated with a malperformance of the implant.Although trunnionosis was noted intraoperatively the root cause cannot be determined and it cannot be confirmed that the trunnionosis was associated with a malperformance of the implant.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: HEMI HEAD44MM
• 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: 8712861
• MDR Text Key: 148444109
• Report Number: 3005975929-2019-00253
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502568
• UDI-Public: 03596010502568
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

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: 74120150
• Device Catalogue Number: 74122544
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71309011 SYN POR PLUS HA SO STEM SZ 11 (B)(6); 74122150 ACETABULAR CUP HAP SIZE 44/50 10083; 74222200 MODULAR SLEEVE PLUS 0MM 12/14 (B)(6); MODR HEAD 44MM 74222144/LOT UNK; MODULAR SLEEVE 74222200/LOT UNK; UNK SIZE 11 POR STEM/LOT UNK; MODR HEAD 44MM 74222144/LOT UNK; MODULAR SLEEVE 74222200/LOT UNK; UNK SIZE 11 POR STEM/LOT UNK
• Patient Outcome(s): Hospitalization; Required Intervention