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

Catalog Number 74120156

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 10/02/2019

Event Type  Injury  

Event Description

It was reported that a right hip revision surgery was performed due to pain, squeaking, popping, metallosis and metal ion elevated.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision the acetabular cup, hemi head and modular sleeve were removed.The anthology stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.Without definitive lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part number for the devices involved in search of complaints involving pain throughout the lifetime of the product.Similar complaints have been identified for the acetabular cup and anthology stem.This will continue to be monitored.Similar complaints have been identified for the hemi head and modular sleeve.However, as the device is no longer sold, no action is to be taken.No lot numbers were provided; hence documentation review could not be completed.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.The available medical documents were reviewed.Based on the provided information, the reported pain, elevated cobalt and chromium levels and intraoperative findings of reactive synovium, evidence of an altr and corrosion may be consistent with findings associated with metal debris.However, without supporting post-primary and pre-revision radiographic images, lab/pathology reports and/or the analysis of the explanted components, the source of the reported findings 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 revision and expected postoperative healing/pain cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.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.

Manufacturer Narrative

D4, udi update.

• 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 9309540
• MDR Text Key: 165980998
• Report Number: 3005975929-2019-00401
• Device Sequence Number: 1
• Product Code: NXT
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2020

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: No Information
• Device Catalogue Number: 74120156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71356107 ANTH HO PO SZ 7; 74122550 HEMI HEAD 50MM; 74222200 MOD SLEEVE {} PLUS 0MM 12/14
• Patient Outcome(s): Hospitalization; Required Intervention