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

Catalog Number UNKNOWN

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 04/05/2021

Event Type  Injury  

Event Description

*us legal * it was reported that, after a revision surgery performed on (b)(6) 2010 where an initial birmingham resurfacing where converted to bhr tha plaintiff has experience a femoral component failure.A second revision surgery was performed on (b)(6) 2021 where the cup, sleeve and head were removed and a oxinium femoral head was implanted instead.Patient outcome is unknown.

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Manufacturer Narrative

H6: it was reported that second left hip revision surgery was performed.During the revision, the head, cup and sleeve were all explanted.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.Since part and lot details were not received for investigation no thorough manufacturing record review or assessment of the reported event can be performed.If the products or additional information become available in the future, the tasks will be reopened and performed.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.Although aseptic loosening was reported, there were no clinical findings in the provided medical documentation to confirm.It is unknown if the vertical acetabular socket position led to accelerated wear and the reported pain and elevated chromium and cobalt levels and fluid collection.Based on the information provided, the clinical root cause cannot be confirmed.It cannot be concluded that the reported clinical reactions are associated with a malperformance of the implant or implant failure.The patient impact beyond the revision cannot be concluded.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 information provided, factors known to contribute to the alleged fault include excessive physical activity levels and loosening of the components, increasing the production of wear particles, accelerating damage to the bone.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.

Manufacturer Narrative

H10.Additional information in b5, b6, b7.Internal reference number: (b)(4).

Event Description

It was reported that, after a revision surgery performed on (b)(6) 2010 where an initial left birmingham resurfacing was converted to a left bhr tha, the plaintiff has experienced pain, aseptic loosening, pseudotumor and elevated chromium and cobalt levels.A second revision surgery was performed on (b)(6) 2021 where the cup, sleeve and head were removed and a oxinium femoral head was implanted instead.Patient outcome is unknown.

• Brand Name: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE
• 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: 12952553
• MDR Text Key: 281853289
• Report Number: 3005975929-2021-00560
• 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
• Report Date: 03/28/2022

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?: 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: 11/16/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 01/17/2022; 03/25/2022
• Supplement Dates FDA Received: 01/28/2022; 03/29/2022
• 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
• Treatment: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male