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 Biocompatibility (2886)

Patient Problems Infiltration into Tissue (1931); Pain (1994)

Event Type  Injury  

Event Description

Bilateral patient.It was reported that, after an unspecified bhr prosthesis construct had been implanted on the patient¿s left hip in or around 2007, the patient has experienced ongoing pain and other unspecified symptoms consistent with metal-on-metal failure.The patient¿s cobalt levels were around the 50¿s (presumably ppb) when a revision surgery of the bhr right hip implants was performed on (b)(6) 2020, the contribution of this hip to the reported cobalt levels could not be discarded at this moment.It is unknown if a revision procedure has already been advised or performed by a health care professional.The patient¿s health status is not known.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: it was reported that, after an unspecified bhr prosthesis construct had been implanted on the patient¿s left hip in or around 2007, the patient has experienced ongoing pain and other unspecified symptoms consistent with metal-on-metal failure.It is unknown if a revision procedure has already been advised or performed by a health care professional, therefore the devices, used in treatment, were not available for analysis.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 and femoral head.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.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (cobalt levels around the 50¿s) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.No further clinical assessment is warranted at this time.Based on the available information we can confirm the reported complaint, however without further information our 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, loosening of components may increase production of wear particles and accelerate 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.

Event Description

Bilateral patient.It was reported that, after an unspecified bhr prosthesis construct had been implanted on the patient¿s left hip in or around 2007, the patient has experienced ongoing pain and other unspecified symptoms consistent with metal-on-metal failure.The patient¿s cobalt levels were around the 50¿s (presumably ppb) when a revision surgery of the bhr right hip implants was performed on (b)(6) 2020 (covered in (b)(4).The contribution of this hip to the reported cobalt levels could not be discarded at this moment.It is unknown if a revision procedure has already been advised or performed by a health care professional.The patient¿s health status is not known.(b)(4).

• 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: 14655054
• MDR Text Key: 293723085
• Report Number: 3005975929-2022-00388
• 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
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• 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?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 69 YR
• Patient Sex: Female