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 Problems Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Toxicity (2333); Test Result (2695)

Event Date 10/15/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery (left body side) due to loosening and chrome and cobalt values > 30.Central cup defect that has to be refilled.Change to nanos stem planned.

Manufacturer Narrative

A bhr cup (details visually confirmed - 74122158, 12bw11164 sn (b)(4) ) and femoral head (details visually confirmed - 74123152, 11fw07900 sn (b)(4) ) were received for investigation following hip revision surgery due to loosening and elevated tests results.A review of the complaint history for the bhr cup and femoral head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup and head.The production records were reviewed for the returned devices which were reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable 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.A wear patch was observed and scratch grooves on the bearing surface of the head.The fixation surface of the head where damage at multiple sites.The bearing surface of the cup where scratch grooves were observed and damage to the rim.Wear analysis was performed to review linear wear on the bearing surface of the head and cup.The wear images identified a wear patch at the edge of the cup which indicates edge loading and on the head showing a wear patch on the bearing surface.Maximum linear wear for the head was 61.2¿m.On the cup, maximum linear wear was 50.5¿m, for a combined head & cup maximum wear of 111.7¿m.Based on historic wear data, after 6.5 years in vivo, the measured combined linear wear is higher than the expected wear for a non-edge loaded smith and nephew large diameter metal-onmetal device.The position of wear on the acetabular cup shows that edge loading has occurred.The available medical documents were reviewed.The reported intraoperative findings of chronic inflammation, effusion and elevated cocr levels may be consistent with findings associated with metal debris.However, without complete supporting medical documents, a thorough investigation cannot be performed and the root cause of the reported event cannot be confirmed.Based on the translation of the provided ct, lab and revision op reports, it is not possible to determine or confirm proper positioning of the implant, or whether the patient had any underlying comorbidities which may have been a contributing factor to the reported and revision.Therefore, it cannot be concluded that the revision was due to a mal-performance of the implant.Based on the returned parts and the information provided the probable root cause is edge loading due to the position of the acetabular cup.If 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: 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 9250425
• MDR Text Key: 164117591
• Report Number: 3005975929-2019-00389
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2017
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 12BW11164
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD 52MM 74123152/11FW07900; FEMORAL HEAD 52MM 74123152/11FW07900
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 74