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

Catalog Number	74120144
Health Effect - Clinical Codes	Pain (1994); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671)
Date of Event	05/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a scheduled bhr right hip revision surgery will be performed due to pain, limited mobility, pseudotumor and elevated metal ion levels.
Additional Manufacturer Narrative
It was reported that a scheduled bhr right hip revision surgery will be performed due to pain, limited mobility, pseudotumor and elevated metal ion levels, to date no revision has been reported.As of today, additional information has been requested for this complaint but has not become available.Without the details of the devices involved in this complaint, the manufacturing review, complaint history review, specific product labelling and ifus & risk management for the devices cannot be reviewed.If this information becomes available at a later time, the task will be reopened and completed.With the limited information provided the root cause of the reported pain, limited mobility, pseudotumour and elevated metal ions cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.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.
Event or Problem Description
It was reported that a bhr right hip revision surgery was performed on (b)(6) 2023.Due to pain, limited mobility, pseudotumor and elevated metal ion levels.The current state of health of the patient is unknown.The primary right hip surgery was performed on (b)(6) 2008.
Event or Problem Description
It was reported that a bhr right hip revision surgery was performed on (b)(6) 2023.Due to pain, limited mobility, pseudotumor and elevated metal ion levels.The revision was completed with an actis size 8 standard offset stem, 28+1.5 biolox delta endoposthetic head, and a smith and nephew polar head, 28.X 50 inside to outside diameters.The primary right hip surgery was performed on (b)(6) 2008, and on 13/may/2016 the patient underwent a right hip aspiration that indicated pink, cloudy synovial fluid as well as elevated metal ion levels.The current state of health of the patient is unknown.

• Brand Name: BIRMINGHAM HIP RESURFACING (BHR)
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone
• MDR Report Key: 9877753
• Report Number: 3005975929-2020-00093
• Device Sequence Number: 469266
• Product Code: NXT
• UDI-Device Identifier: 03596010502537
• UDI-Public: 03596010502537
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/30/2024

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
• Operator of Device: Other
• Device Catalogue Number: 74120144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 10/29/2020; 04/25/2023; 06/28/2023; 04/01/2024; 04/23/2024
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 11/05/2020; 05/03/2023; 07/06/2023; 04/18/2024; 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2746-2015
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74121138 / BHR RESURFACING FEMORAL HEAD 38MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male