MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problems Loose or Intermittent Connection (1371); Insufficient Information (3190)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2019

Event Type  Injury  

Event Description

It was reported that the surgeon revised the patient who had a bhr resurfacing about 12 years ago.The patient has avn of the femoral head and the femoral component was loose.

Manufacturer Narrative

It was reported that hip revision surgery was performed.As of today, device return and additional information has been requested for this complaint but has not become available.No medical documents were received for investigation so a medical review cannot be performed.In the absence of the actual devices, the production records were reviewed for the bhr cup reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The production records for the bhr head weren¿t reviewed as a full part / batch number was not provided.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: device manufacture date.

• Brand Name: ACETLR CUP HAP 52MM 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
• MDR Report Key: 8916365
• MDR Text Key: 155067916
• Report Number: 3005975929-2019-00302
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2009
• Device Catalogue Number: 74120152
• Device Lot Number: 34569
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD 46MM 74121146; FEMORAL HEAD 46MM 74121146
• Patient Outcome(s): Hospitalization; Required Intervention