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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER, GLENOID, PEGGED, CEMENTED, L; ANATOMICA GLENOID COMPONENT

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ZIMMER GMBH ANATOMICAL SHOULDER, GLENOID, PEGGED, CEMENTED, L; ANATOMICA GLENOID COMPONENT Back to Search Results
Model Number N/A
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Date 04/10/2017
Event Type  Injury  
Manufacturer Narrative
Device is not expected, but investigation is in progress: the device will not be returned for analysis as it is still implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The device history records were reviewed and found to be conforming.Surgical reports were received and will be reviewed as part of ongoing investigation.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.Zimmer biomet¿s reference number of this file is (b)(4).The following report is associated with this event: 0009613350-2018-00493.
 
Event Description
It was reported that the patient experiences progressive glenoid radiolucency and is being monitored.Attempts to obtain additional information have been made; however, no more is available.
 
Manufacturer Narrative
Additonal: if follow-up, what type.Correction: date of report, pma/510k.It was discovered that zimmer biomet accidentally created two notifications for the same incident.The same event details and products were reported twice.This case is a duplicate from the original case: (b)(4) with manufacturer report number: 0009613350-2017-00215.Please invalidate this case from your system.Zimmer gmbh will invalidate this case from the system.Zimmer reference number of this file is (b)(4).
 
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Brand Name
ANATOMICAL SHOULDER, GLENOID, PEGGED, CEMENTED, L
Type of Device
ANATOMICA GLENOID COMPONENT
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
MDR Report Key7493500
MDR Text Key107563780
Report Number0009613350-2018-00496
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
PMA/PMN Number
PK990136
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial,Followup
Report Date 10/02/2018
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 Lay User/Patient
Device Expiration Date09/30/2020
Device Model NumberN/A
Device Catalogue Number01.04214.400
Device Lot Number2677693
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/09/2018
Initial Date FDA Received05/08/2018
Supplement Dates Manufacturer Received09/28/2018
Supplement Dates FDA Received10/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SIDUS ANCHOR, ITEM# 01.04555.130, LOT# 2830084; SIDUS HEAD, ITEM# 01.04555.520, LOT# 2829244; SIDUS ANCHOR, ITEM# 01.04555.130, LOT# 2830084; SIDUS HEAD, ITEM# 01.04555.520, LOT# 2829244
Patient Outcome(s) Other;
Patient Age58 YR
Patient Weight120
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