MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122550

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported a right hip revision surgery.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the acetabular cup, hemi head and sleeve were removed.The 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 hemi head, acetabular cup, stem and 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 cup and stem.Similar complaints have been identified for the hemi head and sleeve and this failure will continue to be monitored.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.The reported pain, elevated metal ions and radiological findings of extensive cystic osteolysis of the acetabulum along with intraoperative findings of osteolysis anterior/superior to the acetabulum, marked trunnion corrosion and small benign appearing fluid volume may be consistent with findings associated with metallosis and trunnionosis.However, the root cause of the metallosis and pseudotumor 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 pain, revision, and expected transient post-op convalescence period 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: HEMI HEAD 50MM
• 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: 9283289
• MDR Text Key: 165205211
• Report Number: 3005975929-2019-00392
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 00885556071205
• UDI-Public: 00885556071205
• 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
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/18/2014
• Device Model Number: 74122550
• Device Catalogue Number: 74122550
• Device Lot Number: 09BW04018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71309016 PLUS HA SO STEM, LOT 10GM16674; 74120156 ACETLR CUP, LOT 10CW26309; 74222100 MODULAR SLEEVE, LOT 09EW23322
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR