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 - 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 #: 62109025, description: provisional, articular surface, item #: 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.The event occurred in (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: 8790588
• MDR Text Key: 151109776
• Report Number: 0001822565-2019-02952
• 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: 60267319
• 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