MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 74122546

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

Patient Problems Unspecified Infection (1930); Sepsis (2067); Injury (2348)

Event Date 10/27/2009

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to infection.The head and the sleeve were explanted.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.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.A review of the complaint history for the hemi head 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 sleeve.Similar complaints have been identified for the hemi head.However, as the device is no longer sold, no action is to be taken.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.It was also confirmed that all devices were sterilised.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review could not be performed as hemi heads are no longer sold.As a result, there is no live risk management file to review.The available medical documents were reviewed.The reported drainage, fever, chills, elevated white blood cells, c-reactive protein, erythrocyte sedimentation rate and intraoperative findings of cloudy yellowish fluid may be consistent with infection; however, the root cause of the infection cannot be confirmed.The infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.The patient impact beyond infection, 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: HEMI HEAD 46MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 10331823
• MDR Text Key: 200589187
• Report Number: 3005975929-2020-00271
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071588
• UDI-Public: 00885556071588
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74122546
• Device Catalogue Number: 74122546
• Device Lot Number: 08EW17159
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74222300 / 07FW12486 - MODULAR SLEEVE +4MM 12/14; 74222300 / 07FW12486 - MODULAR SLEEVE +4MM 12/14
• Patient Outcome(s): Hospitalization; Required Intervention