MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120150

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/31/2017

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain, mechanical and aseptic loosening, migration of component, dislocation, leg length discrepancy, loss of mobility and strength.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to severe pain, mechanical loosening, aseptic loosening, migration of component, dislocation, leg length, discrepancy, loss of mobility, and loss of strength.The bhr head and bhr cup were removed during surgery.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.This case re-opened due to the receipt of medical documents i.E.Chart sticks, primary operative and revision notes.It was reported five years post implantation of a rtha this forty-five year old female underwent a revision due to severe pain, mechanical loosening, aseptic loosening, migration of component, dislocation, leg length, discrepancy, loss of mobility, and loss of strength.Revision intra-operative findings; the acetabular component was found to be well attached without signs of damage to the articulating surface.However, the femoral head component was found to be grossly loose and easily removed by simple bone tamp.The revision report confirms the loosening of the femoral head component.However, without the explant or the request clinical information, the root cause of the loosening of the femoral head cannot be determined nor can it be concluded that the reported pain, migration of component, dislocation, leg length, discrepancy, loss of mobility, and loss of strength were associated with the implanted smith and nephew device.However, the patient's history of avn cannot be ruled out as a contributing factor.The future impact to the patient beyond the revision cannot be concluded.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: ACETLR CUP HAP 50MM W/ IMPTR
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 7263346
• MDR Text Key: 99799740
• Report Number: 3005975929-2018-00050
• Device Sequence Number: 1
• Product Code: NXT
• 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: Other,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 74120150
• Device Lot Number: 084657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 74121142/RESURFACING FEMORAL HEAD 42MM/089330 /; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female