MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS HMRL TI TRAY 44MM; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
Event or Problem Description
It was reported the patient was revised approximately three years post-implantation to address in-vivo implant fracture upon involuntary patient movement.No further information is available at the time of this reporting.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was evaluated and the reported event confirmed through photographic inspection.The photograph provided identified fracture of the humeral tray with blood and tissue embedded on the stem.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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: COMP RVS HMRL TI TRAY 44MM
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9568392
• Report Number: 0001825034-2020-00041
• Device Sequence Number: 16252851
• Product Code: KWS
• UDI-Device Identifier: 00880304475335
• UDI-Public: (01)00880304475335
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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 Expiration Date: 06/26/2026
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 411970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 04/09/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 113632 COMP. STEM, LOT 891500; XL-115364, BEARING, LOT 418930; 113632 COMP. STEM, LOT 891500; XL-115364, BEARING, LOT 418930
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 70