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

Catalog Number 00875705201

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Foreign Body Reaction (1868)

Event Date 07/28/2011

Event Type  Injury  

Event Description

It is reported the pt was revised to address symptoms consistent with loosening and metal toxicity.

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 codes: 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

The reported devices are used for treatment.Review of the primary operative surgical notes for procedure performed on (b)(6) 2011 determined that excellent positioning and stability of the construct was confirmed.No complications were indicated.Review of the revision operative surgical notes for procedure performed on (b)(6) 2011 determined that the acetabulum was stable.The removal of ceramic femoral head verified this was without scoring, and no evidence of cobalt/chromium toxicity, eburnation, metal filings or hyper proliferative response of the joint was noted.A likely cause for the reported issue as noted by the surgeon in the postoperative notes is that the external rotators were detached and the patient appeared to have an anterior impingement as the source of his anterior hip pain.

• Brand Name: CONTINUUM TM SHELL WITH CLUSTER HOLES
• 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: 4780256
• MDR Text Key: 18639647
• Report Number: 1822565-2015-00709
• 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
• 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: 01/31/2021
• Device Catalogue Number: 00875705201
• Device Lot Number: 61697332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR