MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD STEM - 6X75MM; PROSTHESIS, SHOULDER

Model Number 211230

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190); Migration (4003)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 05/10/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a comprehensive srs revision due to unknown reasons.No additional patient consequences were reported.Attempts to obtain additional information have been made; however, no more is available at this time. .

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: foreign - (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01275, 0001825034-2022-01276.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

Event Description

No additional event information is available at the time of this report.

Event Description

It was reported that the modular stem moved in situ from the initial surgery due to the overuse of the arm.Subsequently, the patient was revised approximately three years post- initial.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: COMPR SRS MOD STEM - 6X75MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14488840
• MDR Text Key: 292514049
• Report Number: 0001825034-2022-01274
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304507791
• UDI-Public: (01)00880304507791(17)271227(10)242900
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 211230
• Device Catalogue Number: 211230
• Device Lot Number: 242900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2017
• 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: UNK GLENOID.; UNK HUMERAL.
• Patient Outcome(s): Required Intervention; Hospitalization