MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 58MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120158

Device Problems Naturally Worn (2988); Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 02/27/2019

Event Type  Injury  

Event Description

It was reported a right hip revision surgery due to wear on the trunnion, bursitis and elevated metal ion levels.

Manufacturer Narrative

An acetabular cup ((b)(6)) and bhr modular head ((b)(6)) were received for investigation following hip revision surgery for elevated metal ion levels.A review of the complaint history for the head, cup, stem and stem centraliser 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 stem and stem centraliser.Similar complaints have been identified for the cup.This will continue to be monitored.Similar complaints have been identified for the modular head.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known 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.A wear patch was observed on the bearing surface of the modular head.Fine scratches were noted on the bearing surface of the acetabular cup.Wear analysis was performed to review linear wear on the bearing surface of the modular head and acetabular cup.The wear images identified one wear patch on the bearing surface for the head, and a wear patch on the acetabular cup that indicates edge loading.Maximum linear wear for the modular head was 43.6m.On the acetabular cup maximum linear wear was 32.1m, for a combined head & cup maximum wear of 75.7m.Based on historic wear data, after 12.5 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-on-metal device.* the position of wear on the acetabular cup shows that edge loading has occurred.Material loss was measured on the taper of the head.This patient had a right revision 12 years and 5 months post implantation.In 2011 patient had increasing metal ions.In 2013 pataient had complaints of stiffness and severe pain from his lower back on the right side down the back of my right hip and round to the front of my knee.Ultrasound of the right hip showed clear evidence of a complex iliopsoas bursal fluid collection measuring up to 2 cm by 5 cm and evidence of peritrochanteric fluid, along with thinning of the gluteus medius tendon which appears partially deficient, consistent with a partial tear.It was also reported in the complaint that there was wear on the trunnion.A product evaluation noted one wear patch on the bearing surface for the head and a wear patch on the acetabular cup that indicates edge loading.The reported pain, elevated metal ions, and wear on the trunnion along with ultrasound findings of bursal fluid, peritrochanteric fluid and partial tear to the gluteus medius may be consistent with findings associated with metal debris, bursitis and trunnionosis; however, the root cause cannot be confirmed though the report of edge loading cannot be ruled out based on the information provided, and it cannot be concluded that the reported reactions were associated with a malperformance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the parts that were returned and the information given, the probable root cause is improper loading due to the positioning of the cup.If 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.

Manufacturer Narrative

G4 smith and nephew initial date of awareness corrected to (b)(6) 2020.Please disregard (b)(6) 2013, as recorded in our preliminary submission.

• Brand Name: ACETLR CUP HAP 58MM 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: sarah freestone
• MDR Report Key: 9662334
• MDR Text Key: 177542125
• Report Number: 3005477969-2020-00001
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502605
• UDI-Public: 03596010502605
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2010
• Device Model Number: 74120158
• Device Catalogue Number: 74120158
• Device Lot Number: 52604
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2005
• 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: MODULAR HEAD 74121450/ 51719; SPEC EF PRIM 12/14 SZ 3 71312113/ 05MT93945; SPEC INVIS 1313105/ 00710227; MODULAR HEAD 74121450/ 51719; SPEC EF PRIM 12/14 SZ 3 71312113/ 05MT93945; SPEC INVIS 1313105/ 00710227
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male