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U.S. Department of Health and Human Services

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

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ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN ANAVERSE TM PEG Back to Search Results
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).
 
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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 Key11036920
MDR Text Key222317560
Report Number0009613350-2020-00601
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
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 NumberN/A
Device Catalogue NumberUNKNOWN ANAVERSE TM PEG
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/19/2020
Initial Date FDA Received12/18/2020
Supplement Dates Manufacturer Received01/12/2021
Supplement Dates FDA Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age47 YR
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