MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI TRAY STD COCR +3 OFFSET; SHOULDER PROSTHESIS/EXTREMITIES

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01335.Medical products: item#: 110031424, cr vivacit-e 36mm brng std; lot#: 64673389.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.
Event or Problem Description
It was reported that patient underwent a left shoulder arthroplasty approximately five (5) months ago.The patient was revised due to disassociation of item in left shoulder.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01335-1.Visual examination of the returned product identified damage that is seen on the locking features and backside of the bearing.Shallow scratches / damage is also seen in the articulating surface.The tray exhibits damage in the form of scratches / scuff marks.The rim features are rounded.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided but were not submitted as the images attached reflect the same date as the implant date.A definitive root cause cannot be determined.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
No further event information available at the time of this report.

• Brand Name: MINI TRAY STD COCR +3 OFFSET
• Common Device Name: SHOULDER PROSTHESIS/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11819853
• Report Number: 0001822565-2021-01334
• Device Sequence Number: 3223700
• Product Code: KWS
• UDI-Device Identifier: 00887868231346
• UDI-Public: (01)00887868231346(17)291231(10)64634038
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031402
• Device Lot Number: 64634038
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention