MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX FORTE US HD36MM M +4 12/14 TPR +4; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/CERAMIC/METAL,CEMENTEDORUNCEMENTED

Catalog Number 71332085

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Injury (2348)

Event Date 11/15/2018

Event Type  Injury  

Event Description

It was reported that dr.(b)(6) saw a patient in his office because of a ceramic-on-ceramic hip replacement that was done on (b)(6) 2010.The patient had came in with an audible squeak and audible clunk.Dr.(b)(6) revised this patient on (b)(6) 2018.This case was revised to a oxinum head and poly.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and all documents and/or images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.No relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: BIOLOX FORTE US HD36MM M +4 12/14 TPR +4
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/CERAMIC/METAL,CEMENTEDORUNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8305478
• MDR Text Key: 135017729
• Report Number: 1020279-2019-00411
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00885556020241
• UDI-Public: 00885556020241
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2019
• Device Catalogue Number: 71332085
• Device Lot Number: 09EM18686
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71332530/09JT35191; 71335554/09KM07880; 71332530/09JT35191; 71335554/09KM07880
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR