MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR POST; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES

Catalog Number SAGP0002

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 06/06/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a right shoulder revision surgery do to the implants being displaced due to the malpositioning of and loss of fixation of the implants.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01954.Concomitant medical products: item#: sagl2043, modular 4 peg size 3 for cemented use only; lot#: 64813360.Item#: unknown, unknown cement; lot#: unknown.Item#: 113630, comp primary stem 10mm mini; lot#: 65025611.Item#: 113042, versa-dial 46x18x53 hum head; lot#: 467160.Item#: 118001, versa-dial/comp ti std taper; lot#: j7106116.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded as biohazard by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay corrected information.Upon receipt of additional information, it was determined this product should not have been reported as the seating problem did not involve this implant and is now not reportable.This report should be voided as the event was not caused by this product.

Event Description

No further event information available at the time of this report.

• Brand Name: MODULAR POST
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14935838
• MDR Text Key: 295400697
• Report Number: 0001822565-2022-01955
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00889024574495
• UDI-Public: (01)00889024574495(17)300731(10)64760111
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAGP0002
• Device Lot Number: 64760111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female