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

Model Number 74122550

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Toxicity (2333); Test Result (2695)

Event Date 01/23/2018

Event Type  Injury  

Event Description

It was reported that a right hip revision surgery was performed due to elevated metal ions blood, synovial fluid, mild trunnionosis.

Manufacturer Narrative

It was reported that a right hip revision surgery was performed due to elevated metal ions blood, synovial fluid, mild trunnionosis.During the revision, the hemi head and modular sleeve were removed.The acetabular cup and 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.A review of the complaint history for the head / cup / 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 head and sleeve.Similar complaints have been identified for the cup 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.The available medical documents were reviewed.Although it was reported the patient had elevated cobalt and chromium levels, neither the levels nor the lab reports were provided for review.The reported pain and elevated metal ions along with intraoperative findings of a of mild trunnionosis around the trunnion may be consistent with findings associated with trunnionosis.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported elevated metal ions and trunnionosis 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: 9489578
• MDR Text Key: 173272582
• Report Number: 3005975929-2019-00438
• 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: 03/03/2020

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?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2012
• Device Model Number: 74122550
• Device Catalogue Number: 74122550
• Device Lot Number: 10730
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP 74120156/078429; ANTHOLOGY STEM 71356107/06MM02959; MODULAR SLEEVE 74222200/07FW11741
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR