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 Biocompatibility (2886)

Patient Problem Infiltration into Tissue (1931)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Su, e.P., ho, h., bhal, v., housman, l.R., masonis, j.L., noble jr, j.W., & engh jr, c.A.(2021).Results of the first us fda-approved hip resurfacing device at 10-year follow-up.Jbjs, 103(14), 1303-1311.Doi: 10.2106/jbjs.20.01886.

Event Description

It was reported that, on literature review "results of the first u.S fda-approved hip resufacing device at 10 year follow-up.", the number of patients who initially underwent primary implantation of a bhr resurfacing construct and that experienced post-operative cobalt and/or chromium levels in blood greater than seven (7) parts per billion remained similar over time: seven (7) out of two hundred five (205) showed evidence of these levels at one (1) year after the initial surgery, and nine (9) patients out of two hundred four (204) showed evidence during the ten (10) post-operative year follow up.Although it is unknown how this event was addressed on each patient, a revision surgery was not required.Further information was not provided.

Manufacturer Narrative

H3, h6.It was reported that, on literature review "results of the first u.S fda - approved hip resufacing device at ten - year follow - up.", the number of patients who initially underwent primary implantation of a bhr resurfacing construct and that experienced post-operative cobalt and/or chromium levels in blood greater than seven parts per billion remained similar over time: seven out of two hundred five showed evidence of these levels at one year after the initial surgery, and nine patients out of two hundred four showed evidence during the ten post-operative year follow up.Although it is unknown how this event was addressed on each patient, a revision surgery was not required.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.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.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.

• 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: 14743765
• MDR Text Key: 294941333
• Report Number: 3005975929-2022-00403
• 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: Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• 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
• Date Manufacturer Received: 07/15/2022
• 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): Required Intervention