MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 74122546

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

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Metal Related Pathology (4530)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a revision surgery was performed on the patient left hip on (b)(6) 2019.The patient revision surgery was performed due to severe pain, limited mobility, and elevated cobalt and chromium levels.Among the intraoperative findings there was metal debris and adverse local tissue reaction as a result of the premature failure of the device.The patient outcome is unknown.

Manufacturer Narrative

It was reported that hip revision surgery was performed.During the revision the hemi head, modular sleeve and bhr cup were removed.As of today, the implanted devices, all of which were used in treatment and additional information has been requested for this complaint but has 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 this will continue to be monitored.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 a result of the reported event.The available medical documents were reviewed and concluded the clinical information provided, the report of the elevated metal ion levels, the adverse local tissue reaction, the corrosion with oxidized metal present, the periarticular metal on metal wear debris, and the effusion in joint space, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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 preventive or corrective action has been initiated as a result of this investigation.

• Brand Name: HEMI HEAD 46MM
• 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: 11205248
• MDR Text Key: 227917013
• Report Number: 3005975929-2021-00020
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071588
• UDI-Public: 00885556071588
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• 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: 04/14/2021

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: Health Professional
• Device Expiration Date: 07/30/2013
• Device Model Number: 74122546
• Device Catalogue Number: 74122546
• Device Lot Number: 08GW18064
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2021
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SLEEVE 74222300, LOT 08GW17838.; STEM 74435843, LOT 9895.
• Patient Outcome(s): Hospitalization; Required Intervention