MAUDE Adverse Event Report: ZIMMER, INC. CONTINUUM TM SHELL WITH MULTI HOLES; LZO

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Insufficient Information (3190)

Patient Problems Necrosis (1971); Scar Tissue (2060); Reaction (2414); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised due to cup loosening.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products - zimmer m/l femoral stem catalog#: 65771301300 lot#: 61704032, zimmer metasul femoral head catalog#: 00877004002 lot#: 2551906, femoral neck catalog#: 0078480220 lot#: 61699287, zimmer continuum trilogy metasul taper liner catalog#: 00877001140 lot#: 2547779.It has been indicated that the product will not be returned to zimmer biomet, as it was discarded.Reported event was able to be confirmed through the review of operative notes.Dhr was reviewed, and no discrepancies were found.Root cause was unable to be determined as the device was not returned for evaluation.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.

Event Description

It was reported that patient underwent a left hip revision procedure approximately five years post-implantation due to acetabular loosening.Operative notes received noted ambulation difficulties, scar tissue, wear of the femoral head, necrotic tissue and metallosis.The femoral head and acetabular cup were removed and replaced, and an acetabular liner was implanted.No additional patient consequences were reported.

• Brand Name: CONTINUUM TM SHELL WITH MULTI HOLES
• Type of Device: LZO
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5623501
• MDR Text Key: 44119878
• Report Number: 0001822565-2016-01378
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 00875705402
• Device Lot Number: 61697306
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2011
• 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: 68 YR
• Patient Weight: 90