MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR 40MM GLENOSPHERE STD COCR; PROSTHESIS, EXTREMITIES

Catalog Number 110030776

Device Problems Malposition of Device (2616); Scratched Material (3020); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01211, 0001825034-2020-01212.Concomitant medical devices: part#110031421, lot#64343823; part#110031399, lot#64594851; part#118000-00, lot#957120.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that patient under went right reverse shoulder arthroplasty approximately six (6) months ago.Subsequently, the poly bearing disassociated from the tray and patient was revised approximately two (2) months post-implantation.The bearing, tray, and glenosphere were removed and replaced.The glenosphere was found to have been malpositioned and was scratched.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

Event Description

No further event information available at the time of this report.

• Brand Name: CR 40MM GLENOSPHERE STD COCR
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10162432
• MDR Text Key: 195543725
• Report Number: 0001825034-2020-02388
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00887868231254
• UDI-Public: (01)00887868231254
• Combination Product (y/n): N
• PMA/PMN Number: K181611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

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 Catalogue Number: 110030776
• Device Lot Number: 64316096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 80