MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 16MM MINI; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog #: ep-115397, e1 44-41 std +3 hmrl brg, lot # 855930.Catalog #: 115370, comp rvs tray co 44mm, lot # 083410.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01660, 0001825034-2020-01685.Unknown if the product will be returned.
Event or Problem Description
It was reported that the patient had sustained a massive bone fracture, pain and instability and underwent initial right reverse total shoulder on approximately five (5) years ago.Subsequently, the patient underwent a revision of a reverse right shoulder on about two (2) months ago, due to failure of the device when the patient was simply removing a lanyard from his neck.During this revision procedure it was noted the tray had fractured and bearing was noted to have wear.Surgeon was unable to remove the fractured baseplate and elected to remove the well-fixed stem.No complications were reported.No additional information available at this time.
Additional Manufacturer Narrative
(b)(4).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 further reported that the patient's initial surgery occurred approximately four (4) years ago.
Additional Manufacturer Narrative
(b)(4).Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.
Event or Problem Description
Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.

• Brand Name: COMP PRIMARY STEM 16MM MINI
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9977133
• Report Number: 0001825034-2020-01684
• Device Sequence Number: 14267338
• Product Code: HSD
• UDI-Device Identifier: 00880304457546
• UDI-Public: (01)00880304457546
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2020

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 Expiration Date: 06/23/2026
• Device Model Number: N/A
• Device Catalogue Number: 113636
• Device Lot Number: 491360
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/22/2020; 08/05/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/01/2020; 08/14/2020
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 147