MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR HEMI HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74123148
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348); No Code Available (3191)
Date of Event	10/27/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery for left hip due to metal debris, and femoral neck fracture.Cup remained in situ and femoral head was explanted.Replaced with synergy, 48 mm head and sleeve.
Additional Manufacturer Narrative
It was reported that patient underwent a revision surgery for left hip due to metal debris, and femoral neck fracture, following a stumble.During the revision the bhr head was removed.The bhr cup remains implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.According to the provided revision report, the periprosthetic femoral neck fracture occurred while stepping up on a step and stumbled and had immediate pain.Review of the provided implantation and revision report provided no information on potential contributing factor to the fracture.Without x-rays the role of the femoral head position cannot be investigated.Based on the available information the root cause for the revision was an adverse incident due to the patient falling.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: BHR HEMI HEAD 48MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 7824794
• Report Number: 3005975929-2018-00292
• Device Sequence Number: 11084398
• Product Code: NXT
• UDI-Device Identifier: 00885556071847
• UDI-Public: 00885556071847
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 74123148
• Device Lot Number: 13DW10967
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETABULAR CUP 74122154 LOT 13CW13747
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR