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

Catalog Number 00875706001

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 09/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other device used: catalog #00771101020, m/l taper stem, lot #62130196.Catalog #00875101436, continuum, trilogy it, allofit it liner, lot #62157691 - manufactured by zimmer b.V., (b)(4).Catalog #00877503602, biolox delta head, lot #2686825- manufactured by zimmer (b)(4).It was noted from the operative notes that the trial components gave excellent fit and radiographs taken intraoperative ensure the proper sizing and position.Trial components were removed and final components were implanted.Leg lengths were measured to be equalized.Office visit notes state that the x-rays revealed few degrees varus on stem and some lucent lines.No change in position or fracture is noted.It was also noted that the patient's symptoms are concerning for early loosening.Review of the compatibility of the devices confirmed that these are an approved compatible combination.Product history search revealed no additional complaints against the related part and lot combinations.A definite root cause for the patient's pain cannot be confirmed with the informed provided.These devices are used for treatment.

Event Description

It is reported a patient is experiencing pain.

• 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: 5249828
• MDR Text Key: 32105425
• Report Number: 1822565-2015-02467
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 00875706001
• Device Lot Number: 62297507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2013
• 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): Other
• Patient Age: 51 YR
• Patient Weight: 102