MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOLOX DELTA CERAMIC HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Date 05/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will reportedly be returned for analysis, but has not yet been received by the manufacturer; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Concomitant products: 650-1068 biolox option hip system taper adapter lot 692060; ep-200150 active articulation hip system dual mobility bearing lot 404860; unknown femoral stem; unknown acetabular cup.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03852, 0001825034-2017-03856 and 0001825034-2017-03857.

Event Description

It was reported that the ceramic head, taper adapter and dual mobility bearing would not assemble with the existing stem during a revision procedure.Another head, taper adapter and bearing were used to complete the procedure, resulting in a 40 minute delay.There were no additional patient consequences.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the device found scratches and scraping on the rim and outer radius of the head.No dimensional analysis was performed as the alleged failure mode occurred between the sleeve and the stem.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOLOX DELTA CERAMIC HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6642021
• MDR Text Key: 77603643
• Report Number: 0001825034-2017-03852
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK082996
• 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: 09/11/2018

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 2886416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other