MAUDE Adverse Event Report: ZIMMER VERSYS FEMORAL HEAD

Catalog Number 00801803202

Device Problem Off-Label Use (1494)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report was previously submitted under medwatch 1822565-2015-00202.This report will be amended when our investigation is complete.

Event Description

It is reported that the pt underwent a revision due to a mismatch of the femoral head.The surgeon feels that the lettering on the implants is unclear.

Manufacturer Narrative

This report was previously submitted under medwatch 1822565-2015-00202.This report will be amended when our investigation is complete.

Event Description

It is reported that the patient underwent a revision due to a mismatch of the femoral head.The surgeon feels that the lettering on the implants is unclear.

Manufacturer Narrative

This (b)(4) design-controlled device was used for treatment.No devices or associated packaging was returned for further evaluation.Device history records for lot code associated with the reported device were reviewed.No deviations or anomalies were noted with the associated labeling.The device was manufactured, inspected and packaged to specification.The original labels issued for this device were reviewed and confirmed to be legible.The femoral head and liner are etched with the product size specification.This assists in verifying that the appropriate size is present in the box and implanted with identical pairing of devices.

• Brand Name: VERSYS FEMORAL HEAD
• Manufacturer (Section D): ZIMMER ; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5766258
• MDR Text Key: 48728340
• Report Number: 2648920-2015-00187
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2015

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: 12/31/2023
• Device Catalogue Number: 00801803202
• Device Lot Number: 62561461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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): Required Intervention