MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RES

Catalog Number 74122154

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Toxicity (2333); Test Result (2695)

Event Type  Injury  

Event Description

It was reported that high ion metals were detected on the patient.Although the left hip hasn't been revised, due to the nature of the patient risk the left hip can not be disregarded.

Manufacturer Narrative

A2, a3 & d4 added.

Manufacturer Narrative

It was reported that left hip revision surgery was not 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 full documentation review could not be performed as device batch details have not currently been made available.Due to lack of device batch details, a full complaint history review and documentation review could not be performed.A review of the complaint history for the cup and head was performed using part numbers in search of similar recurring reports, involving elevated test results, for the products during their lifetimes.Similar complaints have been identified and this will continue to be monitored.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed.It cannot be determined whether the source of the elevated cocr levels is from the patient¿s left hip device, or if it was a result of the fractured right hip device, as it is reported that the patient has no complaints about his left hip and denies any pain.The patient impact beyond the right hip revision and expected post-operative healing/pain cannot be determined.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance 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: ACETABULAR CUP HAP SIZE 48/54
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RES
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 10138826
• MDR Text Key: 194668519
• Report Number: 3005975929-2020-00188
• Device Sequence Number: 1
• Product Code: NXT
• 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,Followup
• Report Date: 08/14/2020

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: Lay User/Patient
• Device Catalogue Number: 74122154
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 06/30/2020; 06/30/2020
• Supplement Dates FDA Received: 07/04/2020; 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74123148 BHR RESURFACING FEM HEAD 48MM; 74123148 BHR RESURFACING FEM HEAD 48MM
• Patient Outcome(s): Other
• Patient Age: 55 YR