MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122538

Device Problems Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Discomfort (2330); Injury (2348)

Event Date 06/03/2014

Event Type  Injury  

Event Description

It was reported a left hip revision surgery due to pain and discomfort as well as a rubbing sensation in left hip that created an audible squeaking noise and black tissue.Head removed.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the hemi head and modular sleeve were removed.The bhr cup and 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.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.No other similar complaints were identified for the hemi head.Similar complaints have been identified for the sleeve.However, as the device is no longer sold, no action is to be taken.Similar complaints have been identified for the bhr cup.However, as bhr systems of this size are no longer sold, no action is to be taken.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 and no further actions are required at this time.The available medical documents were reviewed.Based on the information provided the reported squeaking, elevated cocr levels and intraoperative findings of fluid and black discolored tissue may be consistent with findings associated with metal debris and trunnionosis.Without supporting postprimary and pre-revision radiographic images, 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 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.

Manufacturer Narrative

New information: g4, d4.

• Brand Name: HEMI HEAD
• 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: 9659472
• MDR Text Key: 177400241
• Report Number: 3005975929-2020-00031
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 74122538
• Device Lot Number: 07DW11422
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71356004 ANTH SO PO SIZE 4 07DM03420A; 74120148 ACETLR CUP HAP 48MM W/ IM 75040; 74222200 MOD SLEEVE PLUS 0MM 12/14 07FW11497
• Patient Outcome(s): Hospitalization; Required Intervention