MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOLOX DELTA HIP SYSTEM MODULAR CERAMIC HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problem Reaction (2414)

Event Date 08/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: g7 acetabular system dual mobility acetabular liner, catalog#: 110024462, lot#: 401090.G7 acetabular screw, catalog#: 010000998, lot#: 3801672.G7 acetabular screw, catalog#: 010000997, lot#: 3753689.G7 acetabular screw, catalog#: 010000999, lot#: 3787070.G7 acetabular screw, catalog#: 010000998, lot#: 3797747.G7 osseo ti 3 hole shell, catalog#: 110010243, lot#: 3795520.Act arctic e1 hip bearing, catalog#: ep-200146, lot#: 678440.Taperloc 133 fp type1 pps, catalog#: 51-100080, lot#: 3755902.Reported event was confirmed by review of x-rays and operative notes.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-04307, 11395, 11396.

Event Description

It was reported that patient was revised approximately 3 months post-operatively due to migration and malalignment of the dual mobility liner.Malalignment/migration were initially noted on radiographs ten days post-implantation.In initial operative notes, surgeon clearly states that there is a possibility of needing a head/liner exchange in future if position of liner changes or symptoms present from the hip.From the revision operative report: patient had significant tendinosis and partial fraying.There was significant metallosis in the hip joint from displacement of metal liner from the cup.Dual mobility head was removed.Trunnion was noted to be mildly scratched with stem well fixed.One of the screws was prominent in the shell and was most likely was the reason for displacement of the liner, according to surgeon.This screw was removed.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that this device was not involved in the event.The initial report was submitted in error and should be voided.

• Brand Name: BIOLOX DELTA HIP SYSTEM MODULAR CERAMIC HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7139560
• MDR Text Key: 95539392
• Report Number: 0001825034-2017-11396
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• 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: 12-115109
• Device Lot Number: 630110
• Other Device ID Number: (01)0 0880304 59158 5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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: 77 YR
• Patient Weight: 83