MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120152

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Test Result (2695)

Event Type  Injury  

Event Description

It was reported that left hip revision is planned due to elevated metal ion levels in blood.

Manufacturer Narrative

It was reported that bilateral patient had elevated metal ion levels.This complaint covers the left side which has not been revised.The implanted devices were all used in treatment.As of today, additional information has been requested for this complaint but have not become available.A review of the complaint history for the bhr cup, hemi head, 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 known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.The root cause of the reported elevated metal ions cannot be confirmed and it cannot be concluded that the reported elevated ions were associated with a mal-performance of the implant.No revision has been reported.Without 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: ACETLR CUP HAP 52MM 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: 10256575
• MDR Text Key: 198291189
• Report Number: 3005975929-2020-00232
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2012
• Device Model Number: 74120152
• Device Catalogue Number: 74120152
• Device Lot Number: 79674
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71357005, LOT # 07FM02635A; HEMI HEAD, # 74122546, LOT # 11340; MODULAR SLEEVE, # 74222100, LOT # 07FW11733; FEMORAL STEM, # 71357005, LOT # 07FM02635A; HEMI HEAD, # 74122546, LOT # 11340; MODULAR SLEEVE, # 74222100, LOT # 07FW11733
• Patient Outcome(s): Required Intervention