MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 7MM MICRO; EXTREMITIES IMPLANTS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a fracture reverse shoulder about 3 years ago.Unfortunately, the primary had failed as the patient suffered a peri-prosthetic fracture below the distal tip of the in-situ stem, while using their arm to push off of a chair.During the revision the existing stem was removed (which took a large chunk of proximal humeral bone with it).The surgeon then reamed down the humeral canal to replace the stem with an srs humeral component.During reaming he found that the reamer skived off an existing cement restrictor form the primary procedure and perforated the humeral canal.He then had to drill in to the cement restrictor to be able to remove it before proceeding with humeral reaming.The surgeon was able to successfully complete the humeral preparation before trialing the new humeral component on the existing in situ glenosphere.The surgeon began with the smallest srs proximal body before building up to the 68mm body.He also trialed a number of humeral tray and poly constructs (from smallest to largest) before settling on the +5mm thickness tray and +3mm thickness poly.This was then implanted before closing up.
Additional Manufacturer Narrative
(b)(4).Mechanical (g04) - stem.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital did not return it.Reported event was confirmed as the radiographs provided showed a fracture.Radiographs identified the following: a reversetype left shoulder arthroplasty is present.There is a comminuted and mildly displaced periprosthetic fracture of the proximal humerus resulting in implant loosening.Glenohumeral implant alignment is maintained without dislocation.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: COMP PRIMARY STEM 7MM MICRO
• Common Device Name: EXTREMITIES IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18574762
• Report Number: 0001825034-2023-03086
• Device Sequence Number: 15398627
• Product Code: HSD
• UDI-Device Identifier: 00880304554085
• UDI-Public: (01)00880304554085(17)271130(10)660360
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2024

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 Model Number: N/A
• Device Catalogue Number: 113607
• Device Lot Number: 660360
• 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: 08/02/2023
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female