MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 13MM STD; PROSTHESIS, SHOULDER

Catalog Number 113653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: versa-dial/comp ti std taper cat# 118001 lot# 168410; comp rvrs shldr glnsp std 41mm cat# 115320 lot# 397490; acrom xl 44-41 std hmrl brng cat# xl-115366 lot# 742400; comp rvs hmrl ti tray 44mm cat# 115340 lot# 988750; comp rvs cntrl scr 6.5x45mm st cat# 115385 lot# 683180; comp non-lckng screw 4.75x40mm cat# 180512 lot# 919380; comp non-lckng screw 4.75x40mm cat# 180512 lot# 490220; comp locking screw 4.75x25mm cat# 180502 lot# 719990; comp locking screw 4.75x25mm cat# 180502 lot# 719990; comp locking screw 4.75x30mm cat# 180503 lot# 003710; comp non-lckng screw 4.75x35mm cat# 180511 lot# 064300.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00306, 0001825034 - 2022 - 00307, 0001825034 - 2022 - 00308, 0001825034 - 2022 - 00309, 0001825034 - 2022 - 00310, 0001825034 - 2022 - 00311, 0001825034 - 2022 - 00312, 0001825034 - 2022 - 00313, 0001825034 - 2022 - 00314, 0001825034 - 2022 - 00315, 0001825034 - 2022 - 00316.

Event Description

It was reported that a patient underwent a revision procedure approximately 7.5 years postimplantation due to pain.During the revision, metal debris was noted, the well fixed stem was explanted, and a proximal humeral fracture occurred and repaired.All components were exchanged without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate complaint.Event will be captured under mfr number: 0001825034 - 2022 - 00452, 0001825034 - 2022 - 00453 , 0001825034 - 2022 - 00454, 0001825034 - 2022 - 00455, 0001825034 - 2019 - 05285-3, 0001825034 - 2022 - 00456, 0001825034 - 2022 - 00457, 0001825034 - 2022 - 00458, 0001825034 - 2022 - 00459, 0001825034 - 2022 - 00460, 0001825034 - 2022 - 00461, 0001825034 - 2022 - 00462.

• Brand Name: COMP PRIMARY STEM 13MM STD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13523148
• MDR Text Key: 285544853
• Report Number: 0001825034-2022-00305
• Device Sequence Number: 1
• Product Code: MBF
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2021
• Device Catalogue Number: 113653
• Device Lot Number: 399260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male