MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROVISIONAL ARTICULAR SURFACE SIZE YELLOW 14 MM HEIGHT; TEMPLATE

Catalog Number 00597103014

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Multiple mdr's were filed for this event.Please see associated: 0001822565 - 2019 - 00394, 0001822565 - 2019 - 02952, 0001822565 - 2019 - 02953, 0001822565 - 2019 - 02959, 0001822565 - 2019 - 02960, 0001822565 - 2019 - 02963, 0001822565 - 2019 - 02964, 0001822565 - 2019 - 02966, 0001822565 - 2019 - 02970, 0001822565 - 2019 - 02971, 0001822565 - 2019 - 02972, 0001822565 - 2019 - 02974, 0001822565 - 2019 - 02976.Concomitant medical products: lot # description item # 62109025 provisional, articular surface 00597103012, 60267319 provisional, articular surface 00597103014, 60702359 provisional, articular surface 00597103014, 62069849 provisional, articular surface 00597103014, 60037678 provisional, articular surface 00597103017, 60718197 provisional, articular surface 00597103017, 61723504 provisional, articular surface 00597103017, 60711711 provisional, articular surface 00597104014, 61716917 provisional, articular surface 00597104014, 60695901 provisional, articular surface 00597104017, 60711697 provisional, articular surface 00597105012, 61704885 provisional, articular surface 00597105014, 61661748 provisional, articular surface 00597105017, 60695888 provisional, articular surface 00597103010, 61354292 provisional, articular surface 00597103010, 62245587 provisional, articular surface 00597103010, 63631356 provisional, articular surface 00597103010, 63631356 provisional, articular surface 00597103010, 63944239 provisional, articular surface 00597103010, 63963834 provisional, articular surface 00597103010, 60263008 provisional, articular surface 00597103012, 60692099 provisional, articular surface 00597103012, 63613874 provisional, articular surface 00597103012, 63661447 provisional, articular surface 00597103012, 63944252 provisional, articular surface 00597103012, 63485270 provisional, articular surface 00597103014, 63620103 provisional, articular surface 00597103014, 63649634 provisional, articular surface 00597103014, 63492795 provisional, articular surface 00597103017, 63624551 provisional, articular surface 00597103017, 63637863 provisional, articular surface 00597103017, 63950874 provisional, articular surface 00597103017, 60711685 provisional, articular surface 00597104010, 63544460 provisional, articular surface 00597104010, 63564705 provisional, articular surface 00597104010, 63649636 provisional, articular surface 00597104010, 63707471 provisional, articular surface 00597104010, 63907831 provisional, articular surface 00597104010, 63923219 provisional, articular surface 00597104010, 60723046 provisional, articular surface 00597104012, 63707472 provisional, articular surface 00597104012, 63729498 provisional, articular surface 00597104012, 63909551 provisional, articular surface 00597104012, 63950876 provisional, articular surface 00597104012, 63963833 provisional, articular surface 00597104012, 64098766 provisional, articular surface 00597104012, 62106300 provisional, articular surface 00597104014, 63624555 provisional, articular surface 00597104014, 63655336 provisional, articular surface 00597104014, 63667496 provisional, articular surface 00597104014, 60263016 provisional, articular surface 00597104017, 62117392 provisional, articular surface 00597104017, 63505873 provisional, articular surface 00597104017, 63612752 provisional, articular surface 00597104017, 63624556 provisional, articular surface 00597104017, 63644014 provisional, articular surface 00597104017, 60706801 provisional, articular surface 00597105010, 63492799 provisional, articular surface 00597105010, 63624557 provisional, articular surface 00597105010, 63644015 provisional, articular surface 00597105010, 63661449 provisional, articular surface 00597105010, 63707475 provisional, articular surface 00597105010, 64135297 provisional, articular surface 00597105010, 60503279 provisional, articular surface 00597105012, 63485275 provisional, articular surface 00597105012, 63649638 provisional, articular surface 00597105012, 63673401 provisional, articular surface 00597105012, 63944254 provisional, articular surface 00597105012, 64135298 provisional, articular surface 00597105012, 60692115 provisional, articular surface 00597105014, 61579539 provisional, articular surface 00597105014, 63492801 provisional, articular surface 00597105014, 63583780 provisional, articular surface 00597105014, 63661450 provisional, articular surface 00597105014, 63661450 provisional, articular surface 00597105014, 62750675 provisional, articular surface 00597105017, 63169365 provisional, articular surface 00597105017, 63490729 provisional, articular surface 00597105017, 63579633 provisional, articular surface 00597105017, 63581233 provisional, articular surface 00597105017.Report source: (b)(6).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 Description

The instruments were returned fractured and/or worn as identified in inventory.No patient or surgical involvement reported.No further information is available at this time.

Event Description

No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The visual evaluation of returned provisional articular surfaces shows signs of repeated use and all of them have been cracked/fractured.The dimensions for these instruments were conforming to prints where measured.This information confirms the reported event.Review of the device history record with receiving inspection report identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue was due to repeated use of these instruments for more than 5-years of field life; which causes wear and tear to the instrument and led to the fracture/cracks.Per package insert (87-6203-999-22 instrument/ provisional use, care and sterilization) inspect all instruments/provisional carefully prior to each use.If damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your zimmer representative for a replacement.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: PROVISIONAL ARTICULAR SURFACE SIZE YELLOW 14 MM HEIGHT
• Type of Device: TEMPLATE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8790590
• MDR Text Key: 152079159
• Report Number: 0001822565-2019-02953
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 00597103014
• Device Lot Number: 60702359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1