MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ANTHOLOGY HIP IMPL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN01101100

Device Problem Biocompatibility (2886)

Patient Problem Metal Related Pathology (4530)

Event Date 10/13/2020

Event Type  Injury  

Event Description

It was reported that, after a tha made on (b)(6) 2018 with implanted anthology hip impl and oxonium femoral head, the patient experienced an advanced metallosis.A revision surgery was performed on (b)(6) 2020 to explant the components.It is unknown what kind of implants were used to replace the explanted ones and if any other treatment or medication was administered to the patient in regards the effect presented.The patient outcome is unknown.

Manufacturer Narrative

H3,h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that per complaint details, ¿the patient experienced an advanced metallosis¿ and underwent revision approximately 2 years post implantation.It is unknown if any other treatment or medication was administered to the patient and the patient outcome is unknown.Responses to the requests for clinical documentation were not provided.The root cause and/or patient impact beyond that which was reported could not be further assessed.Should clinically relevant documentation/information and/or relevant product evaluation results become available, the clinical/medical task may be re-evaluated.No further medical assessment could be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include damaged product, material in use, and patient allergy.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN ANTHOLOGY HIP IMPL
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11816983
• MDR Text Key: 250359079
• Report Number: 1020279-2021-04170
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• 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: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01101100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention