MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Sleep Dysfunction (2517); Metal Related Pathology (4530)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

Complaint reference: (b)(4).

Event Description

It was reported that a revision surgery was performed on the patients left hip on (b)(6) 2019.The revision surgery was performed due to sharp, debilitating nerve pain beginning 2019; pain and stiffness; metallosis; difficulty walking; insomnia and sleeplessness; and other injuries.Among the intra-operative findings and diagnoses were: failed left metal on metal total hip replacement, significant metallosis, pseudotumor, elevated levels of cobalt (20.4 mcg/l) and chromium (2.9 mcg/l), osteolysis with metal debris, and other damage around the left-side hip joint.The patient outcome is unknown.

Manufacturer Narrative

As of today, return of the devices, all of which were used in treatment and additional information has been requested for this complaint but has not become available.The device part details have not been received so a full manufacturing record review cannot be performed.A risk management review was performed.No additional risks were identified as a result of the reported event.The available medical documents were reviewed.Although the reported pain, elevated metal ions and osteloysis may be consistent with findings associated with metallosis; without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the pain, elevated metal ions, osteloysis and metallosis cannot be confirmed and 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.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventive or corrective action has been initiated as a result of this investigation.

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11017066
• MDR Text Key: 221734822
• Report Number: 3005975929-2020-00500
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 02/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention