MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120156

Device Problems Device Appears to Trigger Rejection (1524); Biocompatibility (2886)

Patient Problems Failure of Implant (1924); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 02/26/2019

Event Type  Injury  

Event Description

Us legal.It was reported that the plaintiff underwent a second revision of the left hip on (b)(6) 2019 due to metal-on-metal wear, osteolysis, adverse local tissue reaction, trunionosis, pseudotumor and destruction/detachment of abductor muscles.The cup and the stem were noticed to be well fixed, so they were left in the patient.The metal femoral head was explanted and replaced with a bhr dual mobility liner and an oxinium femoral head.The patient was taken to the recovery room in stable condition.

Manufacturer Narrative

H3, h6: it was reported that a second revision surgery was performed on the patient's left hip.As of today, the implanted devices all of which were used in the treatment, and additional information has been requested for this complaint but has not become available.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history was performed using the part number for 56mm acetabular cup in search of complaints involving osteolysis throughout the lifetime of the product.Similar complaints have been identified and this will continue to be monitored.As no device batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.The parts involved would have met manufacturing specifications at the time of production.If more information is received, this investigation will be reopened.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.The available medical documents have been reviewed.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion.However, the revision operative report indicated the acetabular component was oriented to approximately 25° of anteversion.It is unknown if the increased anteversion led to accelerated wear and the reported elevated cobalt and chromium levels and the intraoperative findings of metal stained tissue, pseudotumour, corrosion and erosion.With the information provided, the clinical root cause of the reported clinical reactions cannot be confirmed, and it cannot be concluded that the reported clinical reactions/events were associated with a mal-performance of the implant or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.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.

• Brand Name: ACETLR CUP HAP 56MM 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 warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 12356548
• MDR Text Key: 267820994
• Report Number: 3005975929-2021-00387
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• 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
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR