MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122158

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pain (1994); Swelling/ Edema (4577)

Event Date 02/02/2012

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

(b)(6).It was reported that, after a right bhr surgery, plaintiff experienced a syncopal episode, also had pain and swelling on right leg.Plaintiff went to emergency room and was found to have a supratherapeutic inr upon admission, and his coumadin was stopped due to concerns for the development of a hematoma in his right thigh.The inr was normalized but the swelling persisted, so a ct scan was performed and a hematoma on right leg was confirmed.Due to this plaintiff underwent coil of the vessel with no complications.Plaintiff outcome regarding this was resolved; however, eventually plaintiff developed metallosis and underwent revision surgery, but this was cover under (b)(4).

Manufacturer Narrative

H3, h6: it was reported that surgery was performed on the patient¿s right hip.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the historical complaints data for the cup and head was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product.No other similar complaints were identified for the cup or head.A search was also performed using part numbers, the reported failure modes and description summary to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.No other similar complaints were found for the cup.Other similar complaints were identified for the head.This will continue to be monitored.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the cup and head.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical information was reviewed.The arterial bleed, hematoma and subsequent coiling of the vessel are related to the supratherapuetic inr and is not associated with the implant.The patient¿s coumadin was stopped and he underwent coiling of the vessel without complication.Without additional information we cannot further investigate or confirm the reported complaint.Based on the information provided, the probable root cause is that the issue is not related to the device and seems to have been caused by something other than the device or usage.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.

• Brand Name: ACETABULAR CUP HAP SIZE 52/58
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• 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: 12773751
• MDR Text Key: 280514472
• Report Number: 3005975929-2021-00499
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 11JW33983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 74123152/FEMORAL HEAD 52MM
• Patient Outcome(s): Hospitalization; Required Intervention