MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE 25 MM POST LENGTH +2 MM LATERAL OFFSET UNCEMENTED; PROSTHESIS, SHOULDER

Catalog Number	00434902502
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ct scan left shoulder following baseplate removal confirms reported event by patient.Notes spacer is present in humerus, humeral head pointed nearly completely anteriorly w/subluxation out of glenoid itself.Periprosthetic fracture of proximal humerus w/callus formation.Comminuted fx of glenoid, bone loss.No indications for revision surgery provided.Cause or reason of scapular fracture is unknown.No indication in surgical report to reflect any fractured components.No shoulder components mentioned within operative report.Note that this procedure took place approximately 6 months after antibiotic spacer placed.Left scapula fracture.Orif left scapula with bone grafting.Products used mesh plate cut and contoured to fit the scapula with a mini-frag plate, most medially.Vivigen and infuse at the fracture site, laid directly underneath the mesh plate with great fixation.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not be determined.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 in a maude report that a patient underwent a shoulder revision approximately two years post implantation due to a broken glenoid.Approximately one month later, the patient alleged their scapula was broken with a ten inch fracture and a one inch displacement.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: BASE PLATE 25 MM POST LENGTH +2 MM LATERAL OFFSET UNCEMENTED
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11841950
• Report Number: 0001822565-2021-01357
• Device Sequence Number: 14437622
• Product Code: KWT
• UDI-Device Identifier: 00889024269033
• UDI-Public: (01)00889024269033(17)260430(10)63347285
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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 Catalogue Number: 00434902502
• Device Lot Number: 63347285
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/18/2021
• 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: Other
• Patient Weight: 56