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

Catalog Number 74122154

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333); No Code Available (3191)

Event Date 01/12/2018

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to wear, soft tissue reaction, pain and elevated ion levels.Patient reported pain, grinding sensation and squeaking from (b)(6) 2016.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to metal wear, soft tissue reaction, pain, squeaking, a grinding sensation, elevated ion levels and metal poisoning the lawsuit alleges the implanted devices were ¿a size 52 acetabular component with lot number 14dw05957 and catalog number 74122154, and a size 46 femoral head with lot number 14dw06292 and catalog number 74123148¿.However, review of the device history records for these alleged part and lot numbers of the implants shows the device sizes to be of 54 and 48 respectively.Should medical records become available in the future, these device records can be further confirmed at that stage.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.No medical documents were provided for investigation.Therefore, the reported event cannot be assessed and a medical investigation cannot 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: BIRMINGHAM HIP RESURFACING
• 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: 8059400
• MDR Text Key: 126915098
• Report Number: 3005975929-2018-00432
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552297
• UDI-Public: 03596010552297
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 74122154
• Device Lot Number: 14DW05957
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74123148, LOT # 14DW06292
• Patient Outcome(s): Hospitalization; Required Intervention