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 Osseointegration Problem (3003)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 01/25/2022

Event Type  Injury  

Event Description

It was reported that on literature review "midterm results of the birmingham hip resurfacing: a single-surgeon series", 2 patients suffered from femoral loosening after a bhr hip resurfacing procedure.The event was treated via revision surgery.The outcome of the patients is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Lass, r., bechler, u., springer, b., rueckl, k., hanreich, c., & boettner, f.(2022).Midterm results of the birmingham hip resurfacing: a single-surgeon series.Archives of orthopaedic and trauma surgery, 1-8.Doi: 10.1007/s00402-021-04305-0.

Manufacturer Narrative

H3, h6: it was reported that on literature review "midterm results of the birmingham hip resurfacing: a single-surgeon series", 2 patients suffered from femoral loosening after a bhr hip resurfacing procedure.The event was tretaed via revision surgery.The outcome of the patients is unknown and no further information is available.The device, used in treatment, was 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.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 required.A risk management review was performed for the 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.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.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, as there were no manufacturing, design or labelling deficiencies identified which would have contributed to the complaint.

• 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: 14438258
• MDR Text Key: 292053679
• Report Number: 3005975929-2022-00281
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• 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: 06/09/2022
• 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 BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TY
• Patient Outcome(s): Required Intervention; Hospitalization