MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD MODULAR HEAD 42 MM +4 (LONG); PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74121542

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

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/07/2019

Event Type  Injury  

Event Description

Local qara.It was reported that a revision surgery was performed on patient's hip on (b)(6) 2019 due to metallosys.The patient outcome it is unknown.

Event Description

It was reported that a revision surgery was performed due to metallosis.Two femoral head parts were reported.It is not know which device was used in relation to the incident.

Manufacturer Narrative

It was reported that hip revision surgery was performed.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 was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.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.The available medical documents were reviewed.Smith and nephew has not received the device/ adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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: MODULAR HEAD 42 MM +4 (LONG)
• 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: 10814949
• MDR Text Key: 215479039
• Report Number: 3005975929-2020-00422
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 03596010503060
• UDI-Public: 3596010503060
• Combination Product (y/n): N
• PMA/PMN Number: K061243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

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: Lay User/Patient
• Device Expiration Date: 04/30/2010
• Device Catalogue Number: 74121542
• Device Lot Number: 51471
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/27/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR HEAD 46 MM -4 (SHORT)/ (B)(6); UNKNOWN BHR ACETABULAR CUP; UNKNOWN FEMORAL STEM; MODULAR HEAD 46 MM -4 (SHORT)/ 74121346/ 51573
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR