MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP AUG MINI BSPLT W TPR LG; EXTREMITIES IMPLANTS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 12/13/2022

Event Type  Injury  

Event Description

It was reported that there was a removal of implants when there was screw breakage and baseplate pullout.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Medical product: catalog #: 115316, comp rvrs shldr glnsp +6 36mm, lot # unknown.Catalog #: unknown, screw, lot # unknown.Report source: france.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00463, 0001825034-2023-00464.

Manufacturer Narrative

(b)(4).Reported event was confirmed as provided radiographs confirm that the screws used to implant the baseplate had fractured as well as lucency.Medical records/radiographs identified the following: overall fit and alignment of the implants is appropriate on the initial images.Fractured glenoid screws and significant osteopenia and lucency along the inferior glenoid on the follow-up images could indicate osteolysis.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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: COMP AUG MINI BSPLT W TPR LG
• Type of Device: EXTREMITIES IMPLANTS
• 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: 16496688
• MDR Text Key: 310809978
• Report Number: 0001825034-2023-00462
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

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 Model Number: N/A
• Device Catalogue Number: 110032430
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 08/14/2023
• Supplement Dates FDA Received: 08/22/2023
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization