MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN ANAVERSE TM PEG

Model Number N/A

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Failure of Implant (1924)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

The investigation of the case and the process of gaining necessary information is ongoing.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.Concomitant medical products: item: anavrs drvr dpsc scr; item#: 01.04440.143; lot#: unknown.Item: anaverse tm peg; item#: 01.04440.144; lot#: unknown.Item: anaverse liner; item#: unknown; lot#: unknown.Item: anaverse baseplate; item#: unknown; lot#: unknown.Item: humeral implant; item#: unknown; lot#: unknown.(b)(4).

Event Description

It was reported that during the revision surgery of the an averse shoulder system, the heads of the anaverse tm pegs broke off during extraction.The rest of the tm peg remained in the glenoid and had to be chiselled out in a very time-consuming process, before they could be pulled out completely with small pliers.Surgical delay duration unknown.The surface area of the glenoid bone was noted as being very hard.

Event Description

See h10.

Manufacturer Narrative

Item# is available now and we recognized that this product type is not registered in the usa.Therefore, please invalidate this case from your system.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: UNKNOWN ANAVERSE TM PEG
• Type of Device: UNKNOWN
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11036920
• MDR Text Key: 222317560
• Report Number: 0009613350-2020-00601
• Device Sequence Number: 1
• Product Code: HSD
• 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: 02/04/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN ANAVERSE TM PEG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR