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

Catalog Number UNKNOWN

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Discomfort (2330)

Event Date 07/17/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

Us legal.Bilateral patient.It was reported that, after a left hip replacement in 2011, plaintiff has experienced a mechanical complication of the left hip replacement, left hip pain, and ongoing discomfort with weight bearing and range of motion.Plaintiff underwent revision surgery on the left hip on (b)(6) 2021.The patient's outcome is unknown.

Manufacturer Narrative

Sections b4, d6a, d6b and h6 were updated due to new information received.

Event Description

Bilateral patient.It was reported that, after a left hip replacement performed on (b)(6) 2010, plaintiff has experienced a mechanical complication of the left hip replacement, left hip pain, and ongoing discomfort with weight bearing and range of motion.Preoperative radiographs revealed questionable neck narrowing with notching inferior to the resurfacing head.Plaintiff underwent revision surgery on the left hip on (b)(6) 2021.During this procedure, the bhr femoral head was resected and a dual mobility system was implanted in exchange.The patient's outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that a left hip revision surgery was performed.As of today, device return and additional information has been requested for this complaint but has not become available.As no device part and batch numbers were provided for the femoral head for investigation, a complaint history review, manufacturing record review, device labelling / ifu review and historical review of the escalation actions could not be performed.If more information is received, this investigation will be reopened.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.The available medical documents were reviewed.The reported pain and discomfort may be consistent with the noted findings of notching of the femoral neck; however, without the information provided the clinical root cause of the reported femoral neck notching cannot be confirmed.The small proximal fracture line posteriorly was identified after usage of the cookie cutter and canal finder.It cannot be concluded that the reported events/ 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 the return of the actual devices or further information we cannot further investigate or confirm the reported complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

Manufacturer Narrative

Section h3, h6: it was reported that a left hip revision surgery was performed.As of today, device return and additional information has been requested for this complaint but has not become available.As no device part and batch numbers were provided for the femoral head for investigation, a complaint history review, manufacturing record review, device labelling / ifu review and historical review of the escalation actions could not be performed.If more information is received, this investigation will be reopened.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.The available medical documents were reviewed.The reported pain and discomfort may be consistent with the noted findings of notching of the femoral neck; however, without the information provided the clinical root cause of the reported femoral neck notching cannot be confirmed.The small proximal fracture line posteriorly was identified after usage of the cookie cutter and canal finder.It cannot be concluded that the reported events/ 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 the return of the actual devices or further information we cannot further investigate or confirm the reported complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement.If the products or additional information become available in the future, this case 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: 14047259
• MDR Text Key: 289335172
• Report Number: 3005975929-2022-00131
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female