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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Anemia (1706); Fever (1858); Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); Electrolyte Imbalance (2196); Abdominal Distention (2601); Hyponatremia (4494)

Event Date 02/23/2010

Event Type  Injury  

Event Description

Us legal mdl: it was reported that, after a bhr construct had been implanted on (b)(6) 2010, the plaintiff experienced anemia, low grade fever, mild hyponatremia, gross hematuria, his blood pressure was dropping, and the creatinine levels raised from 0.9 to 2.1.The plaintiff was treated for the mentioned conditions and was discharged 9 days after the surgery in a stable condition.It is unknown if any specific treatment was applied to the plaintiff.

Manufacturer Narrative

G3, h2, h3, and h6: it was reported that after the bhr construct had been implanted the patient was treated for various conditions, including anemia.The devices, which were used in treatment, remain implanted in the patient and therefore cannot be evaluated, additional information has been requested for this complaint but has 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.One other complaint was noticed relating to this head and cup however it was from the same issue/patient.All the released devices involved met manufacturing specifications at the time of production.It was also confirmed that all devices were sterilized.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.The available medical documents have been reviewed.The reported low-grade fever, mild hyponatremia, gross hematuria, and drop in blood pressure are consistent with the patient diagnosis of postop anemia, hypotension, acute renal failure, and postop ileus which are known complications of surgeries and are related to the procedure and not the device.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.Based on the information it is probable that the adverse event occurred due to known complications of the surgery and is related to the procedure and not the device.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.B7: patient information update.H6: update codes.

• 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: 12044276
• MDR Text Key: 257527501
• Report Number: 3005975929-2021-00323
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Device Lot Number: 099458
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 68 YR