MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 18MM MICRO; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation, however it has not been received.If the device is returned, a new investigation will be conducted and a follow-up mdr will be submitted.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.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.
Event or Problem Description
It was reported that the patient underwent shoulder replacement surgery.During the procedure the surgeon asked for a 18x55 stem.After verifying on the box the correct size, the stem was handed to the circulator to open onto the sterile field.As the surgeon was handed the implant, he noticed that it was way too big compared to what we normally implant.Package was checked and confirmed everything said it was supposed to be a 18x55 micro stem but instead the implant was a 19x122 stem.Knowing another set of micro stems were not available, the surgeon elected to use a mini stem which resulted in a fracture of the humorous.Attempts have been made and no further information has been provided.

• Brand Name: COMP PRIMARY STEM 18MM MICRO
• 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: 12952279
• Report Number: 0001825034-2021-03173
• Device Sequence Number: 20061493
• Product Code: MBF
• UDI-Device Identifier: 00880304554191
• UDI-Public: (01)00880304554191(17)260727(10)005140
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/07/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2026
• Device Model Number: N/A
• Device Catalogue Number: 113618
• Device Lot Number: 005140R
• Was Device Available for Evaluation?: No
• 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: 11/10/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• 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: Required Intervention
• Patient Sex: Unknown