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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 302322493
• Report Number: 0001825034-2022-02014
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00887868267833
• UDI-Public: (01)00887868267833(17)310915(10)65095341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Female