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 Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Arthralgia (2355)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a bhr resurfacing construct had been implanted on the patient¿s right hip on an unspecified date, the patient experienced persistent pain and loosening of the femoral component.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.During this procedure, the bhr femoral head was explanted and replaced with a total hip replacement prosthesis construct.Intraoperatively, the cup was noticed to be well fixed and in good position; therefore, it was not explanted.The patient¿s outcome is unknown.

Event Description

It was reported that, after a bhr resurfacing construct had been implanted on the patient¿s right hip on (b)(6) 2008, the patient experienced persistent pain and loosening of the femoral component.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.During this procedure, the bhr femoral head was explanted and replaced with a total hip replacement prosthesis construct.Intraoperatively, the cup was noticed to be well fixed and in good position; therefore, it was not explanted.The patient¿s outcome is unknown.

Manufacturer Narrative

Additional information: d6a, d10.H3, h6: it was reported that a revision surgery was performed on the patient¿s right hip.As of today the devices used in treatment have been requested but have 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, device labelling and ifu review could not be performed.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.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 information was reviewed.With the information provided the clinical root cause of the reported pain cannot be confirmed.The revision operative report does not confirm the reported ¿loosening femoral component.¿ it cannot be concluded the reported pain is 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 additional information we cannot further investigate or confirm the reported 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.Based on this investigation, the need for corrective or preventative action is not indicated.

Manufacturer Narrative

H10 - additional information: b7 - other relevant history h11 - corrected data: b5 - describe event or problem.D10 - concomitant medical products.E1- initial reporter name and address.G2 - report source.

Event Description

It was reported that, after a bhr resurfacing construct was implanted on the patient¿s right hip on (b)(6) 2008 due to avascular necrosis, the patient experienced persistent pain and loosening of the femoral component.Upon initial implantation surgery, extensive necrotic bone was observed under the femoral articular surface.Even though the area was reamed and all necrotic fragmented bone was removed, the operative report highlighted potential failure due to underlying remaining avascular necrosis; conversion to tha was anticipated.Subsequently, a revision surgery was performed on (b)(6) 2020 to treat this adverse event.During this procedure, the bhr femoral head was explanted and replaced with a total hip replacement prosthesis construct.Intraoperatively, the cup was noticed to be well fixed and in good position; therefore, it was not explanted.The patient¿s outcome is unknown.

Manufacturer Narrative

H3, h6.It was reported that a revision surgery was performed on the patient¿s right hip due to avascular necrosis (avn), pain and loosening of the femoral component.As of today the devices used in treatment have been requested but have not become available.Without definitive part and lot numbers, a complaint history or manufacturing record review cannot be performed for the devices involved.However from the provided implant operative report, it can be determined that the patient was originally implanted with either a 44mm or 46mm resurfacing femoral head, therefore the following reviews are possible.The review of the applicable ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.Prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions required.With the information provided the clinical root cause of the reported pain cannot be confirmed; however, the patient history of avn cannot be ruled out as a possible contributing factor.The revision operative report does not confirm the reported ¿loosening femoral component.¿ it cannot be concluded the reported pain is 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.Based on the information and reports provided our investigation remains inconclusive and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault may include excessive physical activity levels or trauma to the joint replacement.If the products or additional information become available in the future, this case will be reopened.Based on the results of this investigation, the need for corrective or preventative action 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: 14008149
• MDR Text Key: 288586629
• Report Number: 3005975929-2022-00120
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 05/19/2022; 05/11/2023; 06/09/2023
• Supplement Dates FDA Received: 05/25/2022; 05/23/2023; 06/14/2023
• 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
• Removal/Correction Number: Z-2745-2015
• Patient Sequence Number: 1
• Treatment: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP; UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TY; UNKNOWN BHR CUP - 52MM EXT. DIAMETER
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male