MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM 10 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: catalog #: 00434903600, poly liner plus 0 mm offset 36 mm diameter 130, lot # 64596747.Catalog #: 00430901900, unknown, lot #, liner impactor 60 degree 36mm.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01662.

Event Description

It was reported that when the surgeon attempted to impact the poly liner onto the stem it would not fully seat, due to a mis match between the poly liner and stem.The surgeon then had to use a high speed burr to remove part of the poly so it could be impacted on correctly.There was a delay or 10 minutes due to getting the burr to take some of the excess poly off so it would fit the stem.No adverse events have been reported as a result of the malfunction.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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.

Event Description

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

• Brand Name: HUMERAL STEM 10 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12590093
• MDR Text Key: 275170549
• Report Number: 0001822565-2021-02897
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024269937
• UDI-Public: (01)00889024269937(17)300923(10)64811577
• Combination Product (y/n): N
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434901013
• Device Lot Number: 64811577
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 48 YR