MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Tissue Damage (2104)

Event Date 08/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Which exact screw was explanted is unknown.Possible screws include: catalog#: 010000998, lot#: 3801672, expiration date: may 15, 2026, udi #:(b)(4), device manufacture date: may 18, 2016.Catalog#: 010000997, lot#: 3753689, expiration date: mar 1, 2026, udi #: (b)(4), device manufacture date: mar 3, 2016.Catalog#: 010000999, lot#: 3787070, expiration date: apr 21, 2026, udi #: (b)(4), device manufacture date: apr 25, 2016.Catalog#: 010000998, lot#: 3797747, expiration date: may 11, 2026, udi #:(b)(4), device manufacture date: may 16, 2016.Medical product: g7 acetabular system dual mobility acetabular liner, catalog#: 110024462, lot#: 401090.Biolox delta hip system modular ceramic head, catalog#: 12-115109, lot#: 630110.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

This follow-up report is being submitted to relay additional information.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: G7 ACETABULAR SCREW
• 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: 7139568
• MDR Text Key: 95537753
• Report Number: 0001825034-2017-11395
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• 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: SEE H10 NARRATIVE
• Device Lot Number: SEE H10 NARRATIVE
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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