MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX FORTE CER 32 HD 12/14 +8; PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED

Catalog Number 71330328

Device Problem Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 08/15/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to squeaking on (b)(6) 2019.Cup, liner and head were explanted and replaced with new components.Primary surgery was performed on (b)(6) 2008.

Manufacturer Narrative

The associated complaint devices were not returned.The medical investigation concluded that no clinical information has been provided for inclusion in this medical investigation.Should any additional medical information be provided these complaints will be re-assessed.Without the actual product involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: BIOLOX FORTE CER 32 HD 12/14 +8
• Type of Device: PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8967585
• MDR Text Key: 156708949
• Report Number: 1020279-2019-03285
• Device Sequence Number: 1
• Product Code: MRA
• 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: 11/26/2019

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 Catalogue Number: 71330328
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR