MAUDE Adverse Event Report: ZIMMER INC CONTINUUM TM SHELL WITH CLUSTER HOLES; LZO

Catalog Number 00875705201

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.(b)(4).Other devices used: catalog #00625006535, trilogy bone screw, lot #62836978 manufactured by (b)(4); catalog #00784802300, m/l kinectiv neck, lot #62971860; catalog #00885201036, continuum vivacit-e poly liner, lot #62699876 this report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised due to pain and suspected acetabular loosening.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.It has been indicated that the product will not be returned to zimmer biomet.Review of complaint history determined that no further action is required as no trends were identified.Dhr was reviewed and no discrepancies were found.Upon the review of operative notes received, the reported event was confirmed; however, the 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 contribute to monitor for trends.Multiple mdr reports were filed for this event.Please see associated reports: 1822565-2016-00558 and 1822565-2017-01932.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.

Event Description

It was reported that patient underwent a revision procedure approximately 12 months post-implantation due to pain and acetabular loosening.During the procedure, the acetabular screw was also noted to be loose.

• Brand Name: CONTINUUM TM SHELL WITH CLUSTER HOLES
• Type of Device: LZO
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5479972
• MDR Text Key: 39657999
• Report Number: 1822565-2016-00558
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK091508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00875705201
• Device Lot Number: 62831141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2014
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 53