MAUDE Adverse Event Report: ZIMMER GMBH PROTASUL-S-30-HEAD 28 S; PROTASUL HEAD

Catalog Number 30.28.05

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2015

Event Type  Other  

Event Description

It was reported that during the kit inspection in hospital, employees found that the lot numbers and barcode did not match.

Manufacturer Narrative

The manufacturer did not receive devices for review.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Manufacturer Narrative

Additional information received on 04/30/2015.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, as amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Manufacturer Narrative

A technical investigation was not possible to be performed, as the device was not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows: possible route causes: after clarification with the responsible people in italy we come to following conclusion: the wrong lot numbers on the labels were a transmission problem of the hospital fax machine.After looking at the original documents compared to the copies reported in this complaint, it could be clearly determined that the lot numbers on the labels got distorted by the fax machine which led to some wrong numbers resp.Unreadable numbers.Based on the given information and the results of the investigation, the complaint could not be confirmed as there is no product issue.The lot numbers on the labels got distorted by the fax machine.Therefore, it is a process issue in the hospital itself.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that during the kit inspection in hospital employees found that the lot number and the barcode did not match on the label itself.In zimmer's system the lot number was the same as on the barcode on the label.This issue was detected at following ref.- lot.Combinations.- ref.(b)(4) with lot number.2794949 - this combination does not exist in zimmer's system.Ref.(b)(4) with lot number 2789479 - this combination does not exist in zimmer's system.

• Brand Name: PROTASUL-S-30-HEAD 28 S
• Type of Device: PROTASUL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 5742676
• MDR Report Key: 4742840
• MDR Text Key: 16307899
• Report Number: 9613350-2015-00497
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2015

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 Catalogue Number: 30.28.05
• Device Lot Number: 2789478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 04/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/18/2015; 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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