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

Catalog Number 74120154

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); Toxicity (2333); Injury (2348)

Event Date 12/14/2018

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain, discomfort, inflammation, elevated metal ion levels and metallosis.

Manufacturer Narrative

It was reported that right hip revision surgery was 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 complaint history review could not be performed due to lack of device details.A review of the complaint history for the cup and head was performed using part numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified and this will continue to be monitored.No batch numbers were provided; hence documentation review, nor a review for the specific product ifu could be completed.If more information is received, this investigation will be re-opened.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.Although it was reported that the patient had elevated metal ions, no units of measure were given nor was a laboratory report provided.The reported pain and elevated metal ions, along with intraoperative findings of thickened gray, necrotic pseudocapsule, osteolysis in the femoral neck and greater trochanter and an anteverted cup about 70 degrees may be consistent with findings associated metallosis, osteolysis.However, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the psedotumor, osteolysis and metallosis cannot be confirmed.The changes in position could accelerate wear and lead to metal debris and result in metallosis as well.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 re-opened.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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 8437527
• MDR Text Key: 139358764
• Report Number: 3005975929-2019-00143
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

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: Health Professional
• Device Catalogue Number: 74120154
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74123148 FEMORAL HEAD 48MM; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention