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 UNKN01102102

Device Problem Biocompatibility (2886)

Patient Problem Metal Related Pathology (4530)

Event Date 09/17/2013

Event Type  Injury  

Event Description

It was reported that, after a bhr resurfacing construct had been implanted on the patient¿s left hip in 2009, the patient developed hip pain.Due to concerns of metallosis, a revision surgery was conducted on (b)(6) 2013 to treat this adverse event.During this procedure, the bhr acetabular cup was explanted and replaced with a competitors thr system.Intraoperatively, mild amounts of inflammatory tissue were noticed.The patient tolerated well the procedure and was transferred to the pacu unit in stable condition.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Manufacturer Narrative

It was reported that a left hip revision surgery was performed due to pain and concerns of metallosis.Intraoperatively, mild amounts of inflammatory tissue were noticed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu, or definite escalation actions review could not be performed.If more information is received, this investigation will be reopened.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.A review of historic escalation actions for all birmingham hip resurfacing (bhr) acetabular cups and femoral heads, 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 available medical documents were reviewed.The reported pain may be consistent with the intraoperative finding of mild amounts of inflammatory tissue; however, there were no clinical factors found which would have contributed to the mild amounts of inflammatory tissue.The revision operative report did not note findings consistent with metallosis.It cannot be concluded the reported events were associated with a mal performance of the implant.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.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.

• 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: 15254452
• MDR Text Key: 298193672
• Report Number: 3005975929-2022-00460
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

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: UNKN01102102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/23/2022
• 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: 57 YR
• Patient Sex: Female