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

Catalog Number 00875704802

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 05/02/2014

Event Type  Injury  

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to loosening, pain, and infection.

Manufacturer Narrative

(b)(4).No devices or photos were received; therefore the condition of the devices is unknown.The reported devices are used for treatment.It could not be confirmed if the devices were used in an approved and compatible combination.Review of complaint history identified no previous complaints for the part-lot combination of the reported shell.Pre-operative clinic visit notes indicate that patient had drainage from her incision.An infected, loosened failed thr was confirmed.She was noted to have a fibrinous area with purulent drainage.It is stated that the x rays noted an un-cemented total hip with lucency and loose cup.Surgical notes for primary procedure were not provided.Relevant adherence to rehabilitation protocol are unknown.Sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the specified devices caused or contributed to patient infection.

Manufacturer Narrative

Other device used: catalog #00875200832, continuum longevity elevated liner, lot #61979747.Catalog #00801803202, versys femoral head, lot #62338824 - manufactured by zimmer (b)(4).Catalog #00625006535, trilogy bone screw lot #61386237 - manufactured by zimmer (b)(4).Catalog #00625006530, trilogy bone screw, lot #62188072 - manufactured by zimmer (b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported the patient underwent a three stage revision.Components were removed on (b)(6) 2014, additional debridement on (b)(6) 2015 and final implantation on (b)(6) 2015.

• 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: 5157243
• MDR Text Key: 28555377
• Report Number: 1822565-2015-02185
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 00875704802
• Device Lot Number: 61346799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2009
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR