MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD 50/28MM BH DUAL MOBILITY INSERT; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 74121650

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 08/15/2008

Event Type  Injury  

Event Description

It was reported that the patient underwent revision surgery due to post operative infection.During this revision surgery no implants were explanted, a central venous cath placement with guidance was performed.

Manufacturer Narrative

It was reported that the patient underwent revision surgery due to post-operative infection.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 bh dual mobility insert 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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.It was also confirmed that all devices were sterilized.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.Smith and nephew has not received 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: 50/28MM BH DUAL MOBILITY INSERT
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10778721
• MDR Text Key: 214421936
• Report Number: 3005975929-2020-00413
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00885556577240
• UDI-Public: 00885556577240
• 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: 02/11/2021

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 Model Number: 74121650
• Device Catalogue Number: 74121650
• Device Lot Number: A1718649
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention