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 UNKN01102102

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

Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Solid Tumour (4552)

Event Date 02/26/2020

Event Type  Injury  

Event Description

Us legal mdl it was reported that, after a bhr tha construct had been implanted on (b)(6) 2008, the plaintiff experienced elevated metal ion levels, hip pain, pseudotumor, and osteolysis.A revision surgery was performed on (b)(6) 2020 to treat these adverse events.During the surgery, the cup was found to be wrongly positioned and a moderate sized fluid was collected.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that bhr revision surgery of the left hip was performed.As of today, the implanted devices all of which were used in the treatment, and additional information has been requested for this complaint but has not become available.Without definitive lot numbers, a complete complaint history review cannot be performed for the devices involved.As no device batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.All of the devices would have met manufacturing specifications.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.Without the supporting lab/pathology results, imaging, operative reports and/or the analysis of the explanted components, the root cause of the reported pain, elevated metal ions, pseudotumor and osteolysis cannot be confirmed.The reported ¿wrongly positioned¿ acetabular cup cannot be ruled out as a contributing factor to the reported clinical reactions.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.The investigation remains inconclusive and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.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: 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: 12067955
• MDR Text Key: 258367196
• Report Number: 3005975929-2021-00330
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01102102
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention