MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BEARING STANDARD 36 MM DIAMETER; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 110031399, mini humeral tray standard, lot # 64644679.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02013.
Event or Problem Description
It was reported the doctor put the humeral tray and humeral bearing together per surgical technique.The humeral tray and humeral bearing snapped together with no problem.The doctor impacted the humeral tray and humeral bearing component onto humeral stem.As doctor was reducing shoulder, the humeral bearing disengaged from humeral tray.The doctor removed the humeral bearing and humeral tray.Inspected them on the back table and tried putting the components back together again.The humeral tray and humeral bearing separated easily.The doctor then opened new components and implanted them with no problem.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, g4, h1, h2, h3, h6, h10.Visual examination of the returned product identified inspection of each product found little to no damages, however, that damage was around the mating area where the two products join.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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: BEARING STANDARD 36 MM DIAMETER
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10120952
• Report Number: 0001822565-2020-02012
• Device Sequence Number: 16673120
• Product Code: KWS
• UDI-Device Identifier: 00887868231490
• UDI-Public: (01)00887868231490
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 110031418
• Device Lot Number: 64361170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 09/09/2020
• 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