MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® OPTION HD/ADPT, 12/14, 32 X +3.5; BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES

Model Number N/A

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 07/22/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive explanted devices for review.Medical records were received and will be reviewed within the investigation.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 information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that a patient was implanted with a biolox option, head, l, 32/+3.5, taper 12/14 on (b)(6) 2015 on the left hip side and underwent revision surgery on (b)(6) 2016 due to disengagement of the liner from the shell.Note.This is a split case with zimmer inc., (b)(4) reference number (b)(4).

Manufacturer Narrative

It was reported that the patient underwent a revision surgery of the shell, liner and head on left hip due to dislocation and liner disengaged from the shell on (b)(6) 2016.The patient had her primary thr done on (b)(6) 1994.She underwent a revision surgery on (b)(6) 2015 to replace the liner and head.No trend identified.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.The compatibility check was performed from and showed that the product combination was approved by zimmer biomet.A photograph of the ap pelvis view x-ray dated (b)(6) 2016 was received for the review.It is obvious that the femoral component migrated cranially and the ceramic head is not centered anymore with the acetabular shell.The ceramic head is noticed to be in close contact with the metallic shell which indicates that the pe liner is either severely worn laterally or is dissociated from the metallic shell and migrated in caudal direction.Revision surgery report dated (b)(6) 2015: preoperative diagnosis: left hip polyethylene wear, status post uncemented total hip replacement years ago.Postoperative diagnosis: left hip polyethylene wear, status post uncemented total hip replacement years ago.Acetabular liner dislocation.Findings: patient had the liner dislocated.Liner had significant wear.Moderate amount of synovial hypertrophy and metallosis type debris observed.No evidence of infection.Pe liner and ceramic head were replaced by 32/55 pe liner and 32/+3.5mm ceramic head.No other abnormalities observed.Visual examination: biolox option head with the metallic sleeve inside was received as one complete piece for the investigation and was not dissembled as it is not allowed by the patient.Metal transfer of erratic appearance can be found in large amount on the outer surface, which most likely occurred due to the contact with the metallic shell after the disengagement of pe liner from the shell.Metallic transfer on the face of the head can be identified as secondary effects, i.E scratches occurred during the revision surgery.Taper area of the ceramic head cannot observed due to the fact that the device should not be disassembled.However, the metal adapter is observed to be without any significant damages.For the investigation of the case only the explanted ceramic head and the implantation surgery report was received.The revision surgery report was not available.The x-ray analysis shows that the head is dislocated.The visual examination shows that the head has significant amount of metal transfer which confirms the contact with the metallic shell.This leads to the conclusion that either the pe liner is severely worn or it dissociated from the metallic shell, which in return resulted in the dislocation of the ceramic head and the metallic transfer observed.The most likely root cause sourcing from the femoral component is joint laxity or excessive activity level of the patient.The other reasons stemming from the acetabular components can be found in the investigation of the split case (cmp-(b)(4)) reported by zimmer inc.((b)(4)).However, 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 actions is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: BIOLOX® OPTION HD/ADPT, 12/14, 32 X +3.5
• Type of Device: BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
• 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: 5902803
• MDR Text Key: 52941192
• Report Number: 0009613350-2016-01151
• Device Sequence Number: 1
• Product Code: LZO
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-032-03
• Device Lot Number: 2594448
• Other Device ID Number: 00889024430495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2011
• 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 Age: 66 YR
• Patient Weight: 66