MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL GLENOID COMPONENT 46 MM ARTICULAR SURFACE; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately 8 months post implantation, the patient was revised of the left shoulder due to fracturing of the glenoid component.All components were removed and replaced with a spacer.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified additional similar complaints for the reported item ((b)(4)) and no additional complaints for the reported part and lot combination.Medical records were not provided.A field action search using cognos bi identified no quality hold with an r-code as the reason associated with the following part/lot (00432604600/64097389) combination as of 09-sep-2020.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a2, b4, b5, g4, g7, h1, h2, h10.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TRABECULAR METAL GLENOID COMPONENT 46 MM ARTICULAR SURFACE
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 10447702
• Report Number: 3005751028-2020-00074
• Device Sequence Number: 3903567
• Product Code: KWS
• UDI-Device Identifier: 00889024306653
• UDI-Public: (01)00889024306653
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00432604600
• Device Lot Number: 64097389
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 10/01/2020; 12/29/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/02/2020; 01/04/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention