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

Catalog Number 74120152

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); Pain (1994); Toxicity (2333); Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 01/12/2017

Event Type  Injury  

Event Description

It was reported that a left hip revision was performed due to elevated metal ions in blood and urine, audible squeaking and mechanical grinding, pain, pseudotumor, severe lysis, corrosion and metallosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr cup, hemi head and sleeve were removed.The stem 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.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part number for a 52mm bhr cup in search of complaints involving elevated test results throughout the lifetime of the product.Similar complaints have been identified and this will continue to be monitored.As no device batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.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.It cannot be ruled out that the anteverted cup at 30 degrees and 60 degrees abduction led to the accelerated wear and metallosis.The reported pain, elevated metal ions, pseudotumor and intraoperative findings of trunnionosis and alval may be consistent with findings associated with metallosis.However, the root cause of the pain, elevated ions and metallosis cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant versus variation of the initial implant orientation as it is unknown.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.Based on the available information, the suggested root cause for this complaint is improper loading due to the malpositioning of the acetabular component.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: 9699692
• MDR Text Key: 178764170
• Report Number: 3005975929-2020-00053
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 74120152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74122546 HEMI HEAD 46MM.; 74222200 MODULAR SLEEVE {} PLUS 0MM 12/14.; HEMI HEAD UNKNOWN/ UNKNOWN.; MODULAR SLEEVE UNKNOWN/ UNKNOWN.; STEM UNKNOWN/ UNKNOWN.; HEMI HEAD UNKNOWN/ UNKNOWN; MODULAR SLEEVE UNKNOWN/ UNKNOWN; STEM UNKNOWN/ UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention