MAUDE Adverse Event Report: ZIMMER GMBH SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 52-19

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.(b)(4).The following report is associated with this event: 0009613350-2018-00496.

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

Additional: if follow-up, what type correction: date of report, date rec¿d by mfr, 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: 0009613350-2017-00212.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).

• Brand Name: SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 52-19
• Type of Device: SIDUS STEM-FREE SHOULDER
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7493501
• MDR Text Key: 107564288
• Report Number: 0009613350-2018-00493
• Device Sequence Number: 1
• Product Code: PKC
• Combination Product (y/n): N
• PMA/PMN Number: PK171858
• Number of Events Reported: 1
• 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 Model Number: N/A
• Device Catalogue Number: 01.04555.520
• Device Lot Number: 2829244
• Other Device ID Number: 00889024415997
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 09/28/2018
• Supplement Dates FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SHOULDER GLENOID, ITEM# 01.04214.400, LOT# 2677693; SIDUS ANCHOR, ITEM# 01.04555.130, LOT# 2830084; SHOULDER GLENOID, ITEM# 01.04214.400, LOT# 2677693; SIDUS ANCHOR, ITEM# 01.04555.130, LOT# 2830084
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 120