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

Catalog Number UNKN01102106

Device Problems Fracture (1260); Migration (4003)

Patient Problems Failure of Implant (1924); Hip Fracture (2349); Ambulation Difficulties (2544)

Event Date 07/15/2015

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that after a right bhr construct was implanted on (b)(6) 2011, plaintiff experienced disabling pain, inability to ambulate, and fracture of the femoral component with migration.A revision surgery was performed on (b)(6) 2015 to treat these adverse events.During surgery, the femoral neck was found to have a subcapital fracture.The bhr femoral head was explanted, and the cup was found to be stable and remained implanted.The hip was revised to a tha using stryker components.Plaintiff outcome is unknown.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the femoral head was explanted.The acetabular cup remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Without definitive part/lot numbers a review of the historical complaints data cannot be performed for the devices involved.Since part/lot details were not received for investigation no thorough manufacturing record review or assessment of the reported event can be performed.However, the released devices would have met manufacturing specifications at the time of production.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.The available medical documents were reviewed.It should be noted the implantation operative note indicated the initial surgery was a resurfacing.With the limited information provided the root cause of the ¿fracture to the stem of the femoral component along with the fracture and migration of the head¿ cannot be confirmed.It cannot be concluded the reported events were associated with a malperformance of the implant.The patient impact beyond the revision and expected convalescence period cannot be determined.Without the return of the devices used in treatment or additional information we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12857421
• MDR Text Key: 281152775
• Report Number: 3005975929-2021-00538
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01102106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male