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 Material Fragmentation (1261); Patient-Device Incompatibility (2682); Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348); Test Result (2695)

Event Date 02/05/2015

Event Type  Injury  

Event Description

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

Manufacturer Narrative

It was reported that right hip revision surgery was performed.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.No part/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.To date no medical/clinical documentation has been provided.Without any supporting medical documentation, the reported event cannot be assessed, and a thorough medical assessment cannot be performed.In the event of medical/clinical records being received, the clinical task may be re-opened and a thorough assessment will be rendered at that time.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

It was reported that left hip revision surgery was performed.During the revision, the cup, head and sleeve were.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.A review of the complaint history for the bhr cup, hemi head and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the hemi head and sleeve.However, as the device is no longer sold, no action is to be take.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.No further actions are required at this time.The available medical documents were reviewed.Based on the provided information, the reported pain, squeaking, popping, elevated cocr levels and metallosis/adverse local tissue reaction may be consistent with findings associated with metal debris.However, without the revision operative report, 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 malperformance of the implant.The patient impact beyond the revision and expected post-operative 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.

• 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: 9309560
• MDR Text Key: 165973578
• Report Number: 3005975929-2019-00402
• 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: Lay User/Patient
• Device Expiration Date: 08/30/2013
• Device Catalogue Number: 74120156
• Device Lot Number: 092171
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71356107 ANTH HO PO SZ 7 09AM12458; 74122550 HEMI HEAD 50MM 08JW18807; 74222200 MOD SLEEVE PLUS 0MM 12/14 08JW19034; UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD
• Patient Outcome(s): Hospitalization; Required Intervention