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 Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Toxicity (2333); Test Result (2695)

Event Date 10/11/2019

Event Type  Injury  

Event Description

It was reported a left hip revision surgery due to persistent pain, minimally elevated metal ion levels, moderate metallosis.

Manufacturer Narrative

A bmhr head (details not visually confirmed ¿ 74432044, 08bw15837), bmhr stem (details not visually confirmed - 74434630, 07ew10878) and acetabular cup (74122150, 07lw14852 sn (b)(6) were received for investigation following hip revision surgery for pain and minimally elevated metal ion levels.A review of the complaint history for the bhr cup, bmhr head and bmhr stem 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 bmhr head.Similar complaints have been identified for the bmhr stem.However, as the device is no longer sold, no action is to be taken.Similar complaints have been identified for the bhr cup.However, bhr systems of this size are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records for the bhr cup and bmhr stem did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.A non-conformance was raised for the bmhr head related to good documentation practice errors.However, all supporting documents confirm that this was an acceptable product when released.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 on the bearing surface of the head.Discolouration was observed around the wear patch.Fine scratches were observed on the bearing surface of the acetabular cup.Damage was noted on the stem.The stem could not be removed from the head without using excessive force.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.Maximum linear wear for the head was 51.5¿m.On the cup, maximum linear wear was 26.6¿m, for a combined head & cup maximum wear of 88.1¿m.Based on historic wear data, after 11.4 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-on-metal device.The position of wear on the acetabular cup shows that edge loading has occurred.The available medical documents were reviewed.It is unknown if the increased anteversion of 25 degrees led to edge loading and accelerated wear of the prosthesis.Although the reported pain, elevated metal ions and intraoperative findings of pseudocapsule with metallotic abrasive tissue may be consistent with findings associated with pseudotumor and metallosis.The root cause 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.No further clinical assessment is warranted at this time.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 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 9309819
• MDR Text Key: 165980932
• Report Number: 3005975929-2019-00405
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552273
• UDI-Public: 03596010552273
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2012
• Device Model Number: 74122150
• Device Catalogue Number: 74122150
• Device Lot Number: 07LW14852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74432044/ BMHR MOD HEAD 44MM/ 08BW15837; 74434630/ BMHR POR COATED STEM 2/ 07EW10878; 74432044/ BMHR MOD HEAD 44MM/ 08BW15837; 74434630/ BMHR POR COATED STEM 2/ 07EW10878
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 57