MAUDE Adverse Event Report: ZIMMER GMBH WEBER MEDULLARY PLUG

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer did receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

A significant amount of cement has leaked past the plug.

Manufacturer Narrative

Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g4, g7, h10.Event description: it was reported that a significant amount of cement has leaked past the plug.The cement leakage is described as excessive, where the canal is filled with cement to the point that removal is likely to be technically difficult.X-rays: an undated ap view of the right hip was received for investigation.The x-ray shows a cemented stem with a cement plug.Distal to the cement plug some cement leakage can be observed.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.It is assumed that the plug remained implanted.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: due to a ce certification issue allen plugs are currently unavailable and weber plugs were offered as alternative in a field communication.The compatibility matrix does not indicate that weber plugs can be used for allen system.Both surgical techniques describe the use / measuring of the corresponding plug in a comprehensive way.- dhr review: review of the device history records could not be performed due to unknown product identification.Conclusion: it was reported that a significant amount of cement has leaked past the plug.The cement leakage is described as excessive, where the canal is filled with cement to the point that removal is likely to be technically difficult.On the received x-rays some cement leakage distal to the cement plug can be observed.Based on the x-ray the reported event can be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Due to a ce certification issue allen plugs are currently unavailable and weber plugs were offered as alternative.Further investigations were performed which identified the use of unauthorized sizing table and potential issues with sales force communication including potential unclear instructions and not providing proper instrumentation sets.Therefore, based on the investigation it can be concluded that the cause of the reported issue can be traced back to labeling which includes package inserts, instruction manuals & instructions for use.Zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation results are available now.

• Brand Name: WEBER MEDULLARY PLUG
• Type of Device: WEBER MEDULLARY PLUG
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9829087
• MDR Text Key: 193064282
• Report Number: 0009613350-2020-00122
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR