MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS,HIP,HEMI-,TRUNNIONBEARING,FEMORAL,METALPOLYACETAL

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Loss of Range of Motion (2032); Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 03/26/2021

Event Type  Injury  

Event Description

It was reported that on literature review "can hip resurfacing be safely revised with short-stem total hip arthroplasty? a case series of six patients", 1 patient operated in 2004 with bhr presented limited hip mobility and pain at hip rotation since 2016.After diagnosis with acetabular loosening and acetabular bone defect, a revision using competitor's device was performed.At last study follow up, the patient's outcome was excellent.A revision using competitor's device was performed.At last study follow up, the patient's outcome was excellent.

Manufacturer Narrative

H3, h6: it was reported that on literature review: "can hip resurfacing be safely revised with short-stem total hip arthroplasty? a case series of six patients", 1 patient operated in 2004 with bhr presented limited hip mobility and pain at hip rotation since 2016.After diagnosis with acetabular loosening and acetabular bone defect, a revision using competitor's device was performed.At last study follow up, the patient's outcome was excellent.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu, historic escalation actions review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.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 images provided in the article have been interpreted within the text; therefore, no further analysis of the images are required.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 clinical documentation become available in the future, a thorough medical assessment may be rendered at that time.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.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If additional information becomes available in the future, this case 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,HEMI-,TRUNNIONBEARING,FEMORAL,METALPOLYACETAL
• 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: 14318119
• MDR Text Key: 292062021
• Report Number: 3005975929-2022-00189
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization