MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CENTRAL SCREW; SHOULDER PROSTHESIS/EXTREMITIES

Catalog Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 05/25/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01363.D10: medical products: item#: unknown, unknown baseplate/taper; lot#: unknown.G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested from the hospital but not returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that approximately 10 years post implantation of a total shoulder arthroplasty, the patient was revised due to disassociation of the baseplate.During the procedure, it was also noted that the central screw had backed out.The surgeon then drilled for a new central screw and was unable to get the screw to be positioned properly due to alleged boney ingrowth into the baseplate.The surgeon decided to proceed without placement of a central screw, as the baseplate was allegedly well-fixed.Attempts for additional information have been made and none has been provided.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay corrected information.Upon receiving additional information, it was determined that the initial report for this product should be voided as the product and event have been reported previously in medwatch report 0001825034-2023-01408.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.

Event Description

It was reported that approximately 10 years post implantation of a total shoulder arthroplasty, the patient was revised due to disassociation of the baseplate.During the procedure, it was also noted that the central screw had backed out.The central screw was not fully seated during the initial surgery.The surgeon then drilled for a new central screw and was unable to get the screw to be positioned properly due to alleged boney ingrowth into the baseplate.The surgeon decided to proceed without placement of a central screw, as the baseplate was allegedly well-fixed.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01371-2.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6 no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: disassociation of the glenosphere from the glenoid baseplate is identified.Screw appears to be fully seated on this single image.The root cause of the reported issue is attributed to user error.It was reported the screw was not fully seated in the first surgery.The surgical technique gives instructions on how to verify that the screw is seated.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay corrected information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01371-1.The previous supplemental report was forwarded in error.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: disassociation of the glenosphere from the glenoid baseplate is identified.Screw appears to be fully seated on this single image.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: UNKNOWN CENTRAL SCREW
• Type of Device: SHOULDER PROSTHESIS/EXTREMITIES
• 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: 17177643
• MDR Text Key: 317632152
• Report Number: 0001825034-2023-01370
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 10/27/2023

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 08/30/2023; 09/29/2023; 10/26/2023
• Supplement Dates FDA Received: 09/20/2023; 10/04/2023; 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male