MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKN01102102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Metal Related Pathology (4530); Solid Tumour (4552)

Event Date 02/16/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Pietiläinen, s., lindström, m., laaksonen, i., venäläinen, m.S., lankinen, p., & mäkelä, k.T.(2022).Long-term blood metal ion levels and clinical outcome after birmingham hip arthroplasty.Scandinavian journal of surgery, 111(1), 14574969211066197.Doi: doi.Org/10.1177/14574969211066197.

Event Description

It was reported that on literature review "long-term blood metal ion levels and clinical outcome after birmingham hip arthroplasty," 44 patients had pseudotumor with radiologically diagnosis.It is unknown how this were treated.Further information is unknown.

Manufacturer Narrative

Section h10: it was reported that on literature review "long-term blood metal ion levels and clinical outcome after birmingham hip arthroplasty ", 44 patients had pseudotumor with radiologically diagnosis.It is unknown how this was treated.Further information is unknown and 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.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.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.Internal complaint reference number: (b)(4).Section h6 (health code) was corrected.

• Brand Name: UNKNOWN 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: 14312939
• MDR Text Key: 292055838
• Report Number: 3005975929-2022-00205
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01102102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• 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