MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE 15 MM POST LENGTH UNCEMENTED; PROSTHESIS SHOULDER

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem Failure of Implant (1924)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: catalog #: 00434903611, glenosphere 36 mm diameter, lot # 63736820, catalog #: 00434903611, glenosphere 36 mm diameter, lot # 63736820.Reported event was considered confirmed from the medical records and x-rays which found the glenosphere to be dislodged.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-01217 and 0001822565-2018-01218.

Event Description

It was reported that a patient underwent an initial shoulder procedure approximately 3 years ago.Subsequently, the patient was revised due to dislocation about a month later which is been covered under another complaint.However the patient had a second dislocation of the liner and was revised again about a month after the first.During the procedure it was noted that the glenosphere had disassociated from the baseplate.

• Brand Name: BASE PLATE 15 MM POST LENGTH UNCEMENTED
• 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: 10454149
• MDR Text Key: 204374106
• Report Number: 0001822565-2020-02989
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024269969
• UDI-Public: (01)00889024269969(17)270930(10)63755874
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434901500
• Device Lot Number: 63755874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2017
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 100