MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR 4 PEG SIZE 3 FOR CEMENTED USE ONLY; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES

Model Number SAGL2043

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: 0001822565-2022-01955.Medical products: item#: sagp0002, modular post; lot#: 64760111.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 additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.It was alleged that the cement that had been placed on the glenoid component by the surgeon prior to implantation of the component had not been compressed at all and the component had never been fully seated in the prepared glenoid.; however without medical records, a definitive root cause cannot 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.

Event Description

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

• Brand Name: MODULAR 4 PEG SIZE 3 FOR CEMENTED USE ONLY
• 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: 14935950
• MDR Text Key: 295405882
• Report Number: 0001822565-2022-01954
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00889024574373
• UDI-Public: (01)00889024574373(17)280721(10)64813360
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

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 Model Number: SAGL2043
• Device Catalogue Number: SAGL2043
• Device Lot Number: 64813360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female