MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122150

Device Problems Collapse (1099); Patient Device Interaction Problem (4001)

Patient Problems Necrosis (1971); Injury (2348); No Code Available (3191)

Event Date 04/09/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed since femoral head collapse due to the progression of the patient avn disease.

Manufacturer Narrative

A bhr head (details visually confirmed 121142, 23804 sn (b)(6), and bhr cup (details visually confirmed 120150, 24403, sn (b)(6)) which was used in treatment were received for investigation following left hip revision surgery.As of today, additional information has been requested for this complaint but have not become available.A review of the complaint history for the bhr cup and bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.The production records were reviewed for the returned devices reportedly involved in this incident.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.No additional risks were identified as result of the reported event and no further actions are required at this time.Visual inspection was carried out on the returned devices.Fine scratches were observed on the bearing surface of the head.Fine scratches were noted on the bearing surface of the cup.The available medical documents were reviewed.Wear analysis was performed to review linear wear on the bearing surface of the head and cup.The wear images identified a wear patch on the bearing surface for the head, and a wear patch on the bearing surface of the cup.Maximum linear wear for the head was 6.2¿m.On the cup, maximum linear wear was 6.1¿m, for a combined head & cup maximum wear of 12.3¿m.Based on historic wear data, after 15.7 years in vivo, the measured combined linear wear is in line with the expected wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.The position of wear on the acetabular cup shows that the femoral head was articulating within the bearing surface of the cup.The available medical documents were reviewed.The patient¿s preexisting avn cannot be ruled out as a contributing factor to the lucency and subsequent revision.The root cause for the heterotopic ossification cannot be concluded but some patients can be genetically predisposed it is a known complication of joint surgeries and is related to the procedure and not the device.The root cause of the reported pain, minimal lucency and heterotopic ossification cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the available information a root cause cannot be found.If the additional information becomes 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: ACETABULAR CUP HAP SIZE 44/50
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV313 HL; UK CV313HL
• MDR Report Key: 8547502
• MDR Text Key: 143019998
• Report Number: 3005975929-2019-00167
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502773
• UDI-Public: 03596010502773
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2007
• Device Model Number: 74122150
• Device Catalogue Number: OR74121142
• Device Lot Number: 24403
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121142 RESURF FEM HEAD 42MM 23804
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR