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

Catalog Number	110030776
Medical Device Problem Codes	Malposition of Device (2616); Scratched Material (3020); Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: CR 40MM GLENOSPHERE STD COCR
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10162432
• Report Number: 0001825034-2020-02388
• Device Sequence Number: 3852223
• Product Code: PHX
• UDI-Device Identifier: 00887868231254
• UDI-Public: (01)00887868231254
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 80