MAUDE Adverse Event Report: ZIMMER, INC. CONTINUUM TM SHELL WITH CLUSTER HOLES

Catalog Number 00875705601

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 12/10/2012

Event Type  Injury  

Event Description

It is reported the pt was revised due to loosening.The surgeon replaced the shell, liner, and head.

Manufacturer Narrative

Evaluation summary: surgical notes were not provided.X-rays were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Pt factors that may affect the performance of the components such as age, bone quality, height/weight, type of activity (low impact vs.High impact), are unk.Cause cannot be definitively determined.Eval: no devices or photos were received; therefore, the condition of the components is unk.Review of the device history records did not find any deviations or anomalies.It is not suspected that the product failed to meet specifications.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the investigation, the need for corrective action is not indicated.Should additional substantive info be received, the complaint will be reopened.Zimmer, inc.Considers the investigation closed.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This report is being amended to reflect changes.Review of the primary operative surgical notes for procedure performed on (b)(6) 2011 determined that excellent range of motion, stability of the construct was confirmed.No complications were noted.Review of the revision operative notes for procedure performed on (b)(6) 2012 indicated that the stem was well fixed, with no evidence of loosening or micromotion.Boney prominence anteriorly was noted which as suggested by the surgeon, may represent a point of tissue irritation.An acetabular blade was used to free the shell from the adjacent bone, following which deeper blades were applied.As noted, there was no bone posteriorly except for about the central half of the shell and it was prominent anteriorly.The bony prominences, anterior superior and straight anterior were removed with an osteotome.Approximately 1 cm of bone was removed.Based on the information provided, a likely cause for the reported issue is tissue irritation resultant from the bony prominences, as noted during revision surgery.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

The poly liner and shell were returned for further evaluation.The returned liner was damaged with screw holes, fracture, cuts and gouges.The returned shell has surface damage around the rim and inner diameter with gouges and indentations noted.There was evidence of bony on-growth.The damage on both devices is consistent with extraction damage.The shell and liner were 100% inspected and accepted by a certified operator at the time of manufacture.The additional information provided did not alter the conclusion of previously completed complaint investigation.

• Brand Name: CONTINUUM TM SHELL WITH CLUSTER HOLES
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4780229
• MDR Text Key: 5858018
• Report Number: 1822565-2015-00708
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 00875705601
• Device Lot Number: 61757530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CATALOG# 00875101240, LOT# 61713504
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR