MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 6 MM OFFSET 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	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 has been reported after multiple unsuccessful impactions of the poly into the reverse stem using different impactors, it was decided to finish the case using a different implant.
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: POLY LINER PLUS 6 MM OFFSET 36 MM DIAMETER
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9800040
• Report Number: 0001822565-2020-00853
• Device Sequence Number: 610308
• Product Code: HSD
• UDI-Device Identifier: 00889024269071
• UDI-Public: 00889024269071
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K052906
• 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): 06/09/2020

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 Model Number: N/A
• Device Catalogue Number: 00434903606
• Device Lot Number: 64287477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 06/09/2020
• 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