MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 54MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120154

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Type  Injury  

Event Description

It was reported that, after a bhr construct had been implanted on the left side, the patient experienced pain and discomfort.Although the patient has not undergone a revision surgery yet, on (b)(6) 2020 it was confirmed through the medical records that the patient was diagnosed with elevated metal ions on (b)(6) 2016: ions levels of cobalt in blood of 10.9 mcg/l, and chromium in blood 2.7 mcg/l, which are deemed toxic to the organism.The patient outcome is unknown.

Manufacturer Narrative

It was reported that a bilateral patient will undergo a left hip revision surgery.All of the devices were 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 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 hemi head and sleeve.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 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.With the limited information provided, 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.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: ACETLR CUP HAP 54MM 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 warwickshire
• MDR Report Key: 10718907
• MDR Text Key: 212515537
• Report Number: 3005975929-2020-00393
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Model Number: 74120154
• Device Catalogue Number: 74120154
• Device Lot Number: 74251
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (CN: 71306114, LN: 07HM06121).; (CN: 74122546, LN: 10727).; (CN: 74222200, LN: 11041).; (CN: 71306114, LN: 07HM06121).; (CN: 74122546, LN: 10727).; (CN: 74222200, LN: 11041).
• Patient Outcome(s): Other