MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

Where lot numbers were received for the device, the device history record were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).This is a split case with zimmer inc.For the liner.(b)(4).

Event Description

It is reported that the patient was implanted with a biolox® delta, ceramic femoral head, m, 36/0, taper 12/14 on (b)(6) 2012.It is also reported, that the patient felt pain, experienced limited range of motion and x-ray showed that the device has dislocated.The revision surgery was performed on (b)(6) 2016.The head and the liner were explanted.

Manufacturer Narrative

Updates: model #/lot #, date received by mfr, type of reports, if follow-up, what type?, evaluation codes, additional mfr narrative device history records (dhr) review results: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend identified.Event summary: it was reported that the patient underwent a revision surgery on (b)(6) 2016 due to pain, dislocation and loosening after 3 years 8 months in vivo time.In the received per it is stated that the patient had felt pain on the hip and limited movement of the articulation, she did a rx and the implant was resulted subluxate.In the revision surgery head and liner were revised.Review of received data no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis - visual examination: biolox delta head was received as one piece for the investigation.Metal transfer of erratic appearance can be found in large amount on the outer surface and on the taper area of the implant which can be identified as secondary effects.Metal transfer at the surface of the implant is most probably due to contact between the metallic shell and the ceramic head after the loss of connection between the liner and the shell.Erratic metal transfer observed on the face and on the outer chamfer of the ball head is probably due to the contact with the metallic stem during the surgery.On the taper area of the ceramic ball head concentric metal transfer lines are observed which is an indication of a symmetrical taper fit situation between the ceramic head and the metal stem.Review of product documentation - the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Root cause analysis using dfmea: - loss of connection due to inadequate assembling procedure.- possible: as the implantation surgery report is not available for the investigation.- loss of connection, fracture of ceramic head due to particles between stem and head taper.- possible: no surgical report was received to confirm, therefore cannot be excluded.- compromized taper fixation strength, fracture of implant due to high patient activity, patient disregards limits of the device.- possible: patient activity is out of zimmer biomet control.- increased wear, fretting corrosion on stem taper (lever torque) due to patient with high body weight.=> not possible: patient bmi=23.88, which is in the normal range.Conclusion summary neither surgical reports nor the x-rays were received for the investigation of the reported event.Metal transfer seen on the taper surface of the head indicates a correct seating of the ceramic head on the cls stem.The metal transfer at the surface of the ceramic head indicates a contact between the head and a probable metal shell.It is probable that the dislocation of the pe liner (zimmer biomet (b)(4) device) from the metallic shell which happened at an unknown time might have led to the continous contact between head and shell.(the investigation of the pe liner component can be observed in the (b)(4).) based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5818797
• MDR Text Key: 50313294
• Report Number: 0009613350-2016-01080
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

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: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-02
• Device Lot Number: 2658544
• Other Device ID Number: 00889024430365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 65