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 Failure of Implant (1924); Arthralgia (2355); Insufficient Information (4580)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

Bilateral patient.It was reported that after a left bhr performed in march 2013, the patient experienced unspecified symptoms that made a revision surgery necessary, which was performed on (b)(6) 2019.The patient also went to a right bhr performed on (b)(6) 2009.The identity of the explanted devices and the ones implanted in exchange is unknown at this time.No further information is available.

Manufacturer Narrative

H3, h6.It was reported that the patient experienced unspecified symptoms that made a revision surgery necessary, which was performed on (b)(6) 2021.No further information is available and the devices, used in treatment, were not available for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.A risk management review was performed for the acetabular cup.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.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint from a clinical perspective.If additional clinically relevant materials are later received, then the case may be re-evaluated.Without return of the actual devices or further information we cannot further investigate the details supplied in 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.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.H11: corrected information in b5, d6 (it is unknown if the device was explanted) and h6 (updated health effect - impact code).

Event Description

Bilateral patient.It was reported that after a left bhr performed in (b)(6) 2013, the patient experienced unspecified symptoms that made a revision surgery necessary.The left hip was performed on (b)(6) 2019.The identity of the explanted devices and the ones implanted in exchange is unknown at this time.No further information is available.

Event Description

It was reported that, after a left bhr revision surgery performed in 2010, the patient experienced chronic increasing pain and failure of the device that made an additional revision surgery necessary.This revision surgery was performed on (b)(6) 2019.The identity of the explanted devices and the ones implanted in exchange remains unknown.No further information is available.

Manufacturer Narrative

Section h3, h6: it was reported that a left hip revision surgery was performed due to pain and failure of the device.As of today, the implanted device used in treatment has not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, or definite escalation actions review could not be performed.If more information is received, this investigation will be reopened.The review of the product's current ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the acetabular cup.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.A review of historic escalation actions for all acetabular cups and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events cannot be determined with the limited information provided.Based on the information provided we cannot confirm or further investigate the reported 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 device 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) 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
• 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: 14655184
• MDR Text Key: 293723154
• Report Number: 3005975929-2022-00391
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/10/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 07/19/2022; 10/11/2022; 11/09/2022
• Supplement Dates FDA Received: 07/20/2022; 10/13/2022; 11/10/2022
• 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): Hospitalization; Other
• Patient Sex: Female