MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE GELNOSPHERE MINI BASEPLATE WITH TAPER ADAPTER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: catalog #: 110031399, mini humeral tray standard thickness, lot # 64396704; catalog #: 110031418, bearing standard 36 mm diameter, lot # 64343765; catalog #: 113625, comprehensive mini primary stem, lot # 434380; catalog #: 115316, comprehensive reverse glenosphere 36mm, lot # 829820.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 patient; please see all reports associated with this event: 0001825034-2021-00954.

Event Description

It was reported that the patient underwent a shoulder arthroplasty revision approximately six (6) weeks post-operatively to address dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COMPREHENSIVE REVERSE GELNOSPHERE MINI BASEPLATE WITH TAPER ADAPTER
• 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: 12365477
• MDR Text Key: 268063090
• Report Number: 0001825034-2021-02495
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465(17)290925(10)966260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 010000589
• Device Lot Number: 966260
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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