MAUDE Adverse Event Report: ZIMMER ZIMMER TM SHELL WITH CLUSTER HOLES

Catalog Number 00620005222

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 10/31/2014

Event Type  Injury  

Event Description

It was reported the patient was revised due to the acetabular component loosening.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: ZIMMER TM SHELL WITH CLUSTER HOLES
• Manufacturer (Section D): ZIMMER; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4316507
• MDR Text Key: 15808223
• Report Number: 2648920-2014-00347
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 00620005222
• Device Lot Number: 61511477
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2010
• 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: 88 YR