MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE PT HYBRID GLEN POST REGENEREX; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog #: 113954, md hybrid glenoid base 4mm, lot # 293790, catalog #: 406669, stn pn thd tip.125x2.5in 2pk, lot # 745160, catalog #: 113633, comp primary stem 13mm mini, lot # 180300, catalog #: 118001, versa-dial/comp ti std taper, lot # 497590, catalog #: 113046, versa-dial 46x24x47 hum head, lot # 753240.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is unknown where the device is.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05038.Product location is unknown.
Event or Problem Description
It was reported that the patient received an initial left shoulder arthroplasty approximately a year ago.Subsequently a revision occurred about 2 months ago due to a loosening baseplate and bone erosion.
Additional Manufacturer Narrative
(b)(4).Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.
Event or Problem Description
Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.

• Brand Name: COMPREHENSIVE PT HYBRID GLEN POST REGENEREX
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9307715
• Report Number: 0001825034-2019-05076
• Device Sequence Number: 2104667
• Product Code: KWS
• UDI-Device Identifier: 00880304459854
• UDI-Public: (01)00880304459854
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K060694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: PT-113950
• Device Lot Number: 724320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 04/30/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 105