MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI TRAY +5MM COCR +3 OFFSET; SHOULDER, PROSTHESIS

Model Number	110031403
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cr prolong 36mm brng +3, cat: 110031419, lot: 64343816; comp rvrs shldr glnsp std 36mm, cat: 115310, lot: 162810.One mini tray, taper adaptor and bearing were returned for evaluation.Visual inspection identified damages in the form of scratches and scuffings on the devices.The damages were likely caused during removal.The dimensional analysis of tray were conforming to specifications during manufacturing.The dimensional analysis of the bearing cannot be performed due to the nature of the damages.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.Upon receipt of additional information it has been determined that the reported device was initially reported under the incorrect manufacturing site: 0001825034-2020-02768.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 the patient underwent a revision due to the poly disassociating from the tray.

• Brand Name: MINI TRAY +5MM COCR +3 OFFSET
• Common Device Name: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11776444
• Report Number: 0001822565-2021-01259
• Device Sequence Number: 3138144
• Product Code: KWS
• UDI-Device Identifier: 00887868231353
• UDI-Public: (01)00887868231353
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 110031403
• Device Catalogue Number: 110031403
• Device Lot Number: 64420199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 96