MAUDE Adverse Event Report: ZIMMER GMBH AVENIR MÜLLER, STEM, STANDARD, UNCEMENTED, HA, 1, TAPER 12/14; AVENIR MULLER STEM

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive devices for review.Other source documents were not provided for review.Where lot numbers were received for the device, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Additional information has been requested and is currently not available.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that during a total hip prosthesis surgery, the stem has fallen on the floor because the inner sterile package was not sealed.The surgery was completed with another product (same size).

Manufacturer Narrative

Investigation results were made available.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: bag not sealed review of event description: it was reported that during surgery the surgical staff opened the package and during that procedure the implant fell on the floor because the inner sterile bag was not sealed on one end.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: the product with the packaging were returned for investigation.The visual examination shows that the protection bag (svp) and the outer bag (avp) were opened as intended.On the inner sterile bag (ivp), there is no seal visible on one side.It looks like an unsealed bag.No other conspicuousness could be found.Review of product documentation: reviewing the dhr 2923038, it can be determined that the lot was packed by the supplier medicoat sas.It was reported that during surgery the surgical staff opened the package and during that procedure the implant fell on the floor because the inner sterile bag was not sealed on one end.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.The lot 2923038 was packed by the supplier medicoat sas.The product with the packaging was returned for investigation.The visual examination shows that the protection bag (svp) and the outer bag (avp) were opened as intended.On the inner sterile bag (ivp) there is no seal visible on one side.It looks like an unsealed bag.No other conspicuousness could be found.Based on the investigation it can be determined that the root cause for the reported error pattern is a manufacturing issue at the supplier medicoat sas.Based on the available information, an issue evaluation has been initiated to determine the necessity of potential corrective and/or preventive actions.Should the results of this issue evaluation indicate the necessity of a remedial action/corrective action/preventive action/field safety corrective action, an updated report will be submitted.Zimmer biomet's reference number of this file is (b)(4).

Event Description

No event update.

• Brand Name: AVENIR MÜLLER, STEM, STANDARD, UNCEMENTED, HA, 1, TAPER 12/14
• Type of Device: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7547760
• MDR Text Key: 109366376
• Report Number: 0009613350-2018-00548
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK123392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.001
• Device Lot Number: 2923038
• Other Device ID Number: 00889024479456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/28/2018
• Supplement Dates Manufacturer Received: 10/26/2018
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other