MAUDE Adverse Event Report:; HEAD, FEMORAL, CERAMIC, BILOX DELTA, 32MM -4.0

Catalog Number 400-03-321

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Corrected data: original initial report was submitted as follow up in error.

Event Description

Primary surgery complaint - the representative opened a 32 -4 ceramic head and it would not fit the trunion of the linear stem, there was an obvious mismatch.The representative opened another size 32 -4 ceramic head with the same lot number and reference number on the box and it was the correct implant.Neither implant should have had to use an adaptor.

• Type of Device: HEAD, FEMORAL, CERAMIC, BILOX DELTA, 32MM -4.0
• MDR Report Key: 10614468
• MDR Text Key: 209584643
• Report Number: 1644408-2016-00347
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 400-03-321
• Device Lot Number: 860B1063
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other