MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 54MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 74120160

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

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Toxicity (2333)

Event Date 03/27/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patient's right hip on (b)(6) 2018, due severe pain, limited mobility, metallosis, elevated cobalt and chromium levels, and trunnionosis.Among the intra-operative findings and diagnoses were: elevated cobalt and chromium levels, trunnionosis and metallosis as a result of the premature failure of the devices.The patient outcome is unknown.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the head and sleeve were removed.The cup 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 acetabular 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 acetabular cup and hemi head.Similar complaints have been identified for the modular sleeve.However, as the device is 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.All the released devices involved met manufacturing specifications at the time of production.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.Patient had bilateral tha¿s in 2009.He had a right revision (b)(6) 2018.Elevated metal ions were reported, but no lab values or laboratory reports were provided.The revision operative reports indicated well positioned acetabular and femoral components, no visible wear on the acetabular socket, mild trunnion corrosion; no evidence of infection.Although the reported pain, elevated cobalt and chromium levels may be consistent with findings associated with trunnionosis and metal debris; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the pain, elevated cobalt and chromium levels, 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 54MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10581084
• MDR Text Key: 208369585
• Report Number: 3005975929-2020-00354
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 03596010502612
• UDI-Public: 03596010502612
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2012
• Device Model Number: 74120160
• Device Catalogue Number: 74122554
• Device Lot Number: 07KW14323
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SLEEVE 74222100, LOT 08AW152487135; STEM 71357108, LOT 07HM18607B; SLEEVE 74222100, LOT 08AW152487135; STEM 71357108, LOT 07HM18607B
• Patient Outcome(s): Hospitalization; Required Intervention