MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 16MM MINI; EXTREMITIES IMPLANTS

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was reamed and broached to 16mm and the 16mm stem would not fully seat.It was stated that the stem was 1-2mm proud.
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 405800, comp.Rev shldr 9 in steinmann, lot # 334840, catalog #: 405889, comp rvs 2.7mm dia drl, lot # 364060, catalog #: 405883, comp rvs 3.2mm drl, lot # 665020, catalog #: 113034, versa-dial 42x21x43 hum head, lot # j7156453, catalog #: 118001, versa-dial/comp ti std taper, lot # j7073921, catalog #: 110035767, comp conv glen liner vivacit-e, lot # 65163941, catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 126250, catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 125830, catalog #: 115395, comp rvs cntrl 6.5x25mm st/rst, lot # 182620, catalog #: 110005273, comp cnv glen base non ha, lot # 112850, and catalog #: 113635, comp primary stem 15mm mini, lot # 65301005.Reported event was not confirmed as visual examination of the returned product identified stem reveals cosmetic scratches on the distal end, around the collar face, and nicks along the edges of the porous coating.Dimensional analysis was performed on the porous coated area and overall length and found to be conforming.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to no problem found as the returned device was found to have conforming measurements.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 16MM MINI
• 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: 15642302
• Report Number: 0001825034-2022-02014
• Device Sequence Number: 5678082
• Product Code: HSD
• UDI-Device Identifier: 00887868267833
• UDI-Public: (01)00887868267833(17)310915(10)65095341
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K060692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113636
• Device Lot Number: 65095341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• 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: 06/08/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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
• Patient Sex: Female