MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HEAD, 12/14, 36 X -3.5; BIOLOX DELTA CERAMIC FEMORAL HEAD

Catalog Number 00-8775-036-01

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 04/28/2015

Event Type  Injury  

Event Description

It was reported that a biolox delta head, 12/14, 36 x -3.5 was implanted on (b)(4) 2011 on the right side.The pt underwent a revision surgery on (b)(6) 2015, due to mechanical failure.It was reported by the surgeon that the liner was confirmed broken on the outer rim just above the locking ring mechanism.The locking ring was still functioning properly.

Manufacturer Narrative

The manufacturer did not receive devices for review.Surgical reports and x-rays were received.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the info provided.Should additional info become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Manufacturer Narrative

No trend identified.The product combination used was approved by zimmer.The received biolox delta head shows metal contact specifically located on a relatively small area of the articulating surface.It is highly possible that the breakage of the liner and subsequent disassociation of the liner from the cup led to the contact between the head and the metal back of the cup.The received x-rays prove the dissociation of the head from the liner.Based on the given information and the results of the investigation, it was not possible to identify a specific root cause for the reported event.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.

• Brand Name: BIOLOX DELTA HEAD, 12/14, 36 X -3.5
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676
• MDR Report Key: 4797728
• MDR Text Key: 5832234
• Report Number: 9613350-2015-00612
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 00-8775-036-01
• Device Lot Number: 2552365
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 114