MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120160

Device Problem Metal Shedding Debris (1804)

Patient Problem Reaction (2414)

Event Date 10/09/2015

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to an adverse reaction to metal debris and metallosis.

Manufacturer Narrative

It was reported that revision surgery was performed due to armd and metallosis.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.Device history record review confirmed that all released parts met specifications applicable at the time of production.Since no underlying medical documents were received for investigation, no thorough medical investigation and assessment of the reported complaint can be performed.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.

• Brand Name: BHR ACETABULAR CUP 60MM
• Type of Device: 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
• MDR Report Key: 7633741
• MDR Text Key: 112168692
• Report Number: 3005975929-2018-00234
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502612
• UDI-Public: 03596010502612
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2010
• Device Catalogue Number: 74120160
• Device Lot Number: 50934
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 10/19/2018
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74121154, LOT # 50611; FEMORAL HEAD, # 74121154, LOT # 50611
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR