MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI HUMERAL TRAY +10 MM THICKNESS +3 MM TAPER OFFSET 40 MM; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a shoulder replacement surgery on an unknown date with competitor devices and subsequently revised on unknown date using zimmer bio met products.Again the patient was revised second time less than two months later due to loosening of the humeral tray.The tray and bearing were replaced with no allegations against the bearing.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 110031427, cr vivacit-e 40mm brng std, 64354398.Item #: unknown, unknown humeral stem, lot #: unknown.Item #: unknown, unknown glenosphere, lot #: unknown.Item #: unknown, unknown glenoid baseplate, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.Reported event was confirmed by review of medical records and examination of device.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Visual examination of the returned product and provided pictures identified a reverse shoulder mini humeral tray (part 110031404) was returned for evaluation.As returned, scratches were seen on the backside of the tray and the side/rim exhibits surface damage.Medical records reviewed by a health care professional identified the following: two views of the right shoulder demonstrate a reverse total shoulder arthroplasty with inferior positioning of the glenosphere.First image demonstrates possible dislocation of the glenohumeral joint and second image demonstrates implant disassembly with the humeral tray seen inferior and medial in position.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: MINI HUMERAL TRAY +10 MM THICKNESS +3 MM TAPER OFFSET 40 MM
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13238514
• Report Number: 0001822565-2021-03564
• Device Sequence Number: 4243911
• Product Code: KWS
• UDI-Device Identifier: 00887868231360
• UDI-Public: (01)00887868231360(17)290630(10)64437449
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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: N/A
• Device Catalogue Number: 110031404
• Device Lot Number: 64437449
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male