MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 38MM

Catalog Number 74121138

Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 09/24/2018

Event Type  Injury  

Event Description

It was reported that left hip revision was performed due to pain and other complications.

Event Description

It was reported that left hip revision was performed due to pain and other complications.Bhr cup remained implanted.Bilateral patient with right side devices still implanted (see c-0212780).Subsequent revision recorded in c-0212726.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the femoral head was removed.The bhr cup remained 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.The available medical documents were reviewed.This 65-year-old female with a bmi= 36.1 and many co-morbid conditions, had her primary bhr resurfacing hip performed in november 2010.It was revised 19 days later secondary to multiple dislocations.The root cause for the first revision cannot be concluded.It is unknown if the patient¿s body habitus and early weight bearing contributed to the dislocations and subsequent revision.All the released devices involved met manufacturing specifications at the time of production.Further, 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.Additional information: event, brand name, concomitant medical products and pma/510k.

• Brand Name: RESURFACING FEMORAL HEAD 38MM
• Type of Device: RESURFACING FEMORAL HEAD
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 7972892
• MDR Text Key: 123934713
• Report Number: 3005975929-2018-00380
• Device Sequence Number: 1
• Product Code: NXT
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Catalogue Number: 74121138
• Device Lot Number: 67375
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: ACETLR CUP HAP 46MM W/ IMPTR 74120146/ 74757
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR