MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122550

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

Patient Problems Pain (1994); Injury (2348)

Event Date 10/17/2019

Event Type  Injury  

Event Description

It was reported a right hip revision surgery due to persistent pain and extensive trunnionosis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the hemi head and modular sleeve removed.The echelon stem and acetabular cup 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.A review of the complaint history for the hemi head, acetabular cup, modular sleeve and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the 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.The available medical documents were reviewed.The reported pain and intraoperative findings of extensive trunnionosis may be consistent with findings associated with metal debris.However, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain and trunnionosis cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, 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 50MM
• 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: 9671699
• MDR Text Key: 177815589
• Report Number: 3005975929-2020-00041
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 00885556071205
• UDI-Public: 00885556071205
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/29/2012
• Device Model Number: 74122550
• Device Catalogue Number: 74122550
• Device Lot Number: 07KW14092
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ECH PRI STEM 71341016/ (B)(6).; MODULAR SLEEVE 74222100/ (B)(6).; ECH PRI STEM 71341016/ 00808946A; MODULAR SLEEVE 74222100/ 07LW14954
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR