MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER VERSYS FEMORAL HEAD; HIP PROSTHESIS

Catalog Number 00801803602

Device Problem Insufficient Information (3190)

Patient Problems Rash (2033); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that a patient was experiencing a rash and high ion levels.

Manufacturer Narrative

This follow up report is being filed to relay additional and corrected information.Device 3 of 5: reference mfr.Reports: 1822565-2014-00233,1822565-2016-04081, 2648920-2017-00064 & 1822565-2016-04083.

Manufacturer Narrative

No devices were received; therefore the condition of the components is unknown.Device history review for all related devices identified no deviations or anomalies.The devices were used for treatment.The reported components were reviewed for compatibility with no issues noted.A complaint history search for all related devices identified no additional complaints with the same part/lot number combinations.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.No photos or additional information was provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: ZIMMER VERSYS FEMORAL HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6078818
• MDR Text Key: 59165540
• Report Number: 0002648920-2016-03255
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2017

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: 11/26/2022
• Device Catalogue Number: 00801803602
• Device Lot Number: 62232596
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/20/2017; 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2012
• 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 Weight: 77