MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR; SHOULDER, PROSTHESIS

Model Number	118000
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient was revised approximately two weeks post implantation due to disassociation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Visual examination of the returned product/provided pictures identified no damage noticed to the threads.Scratches and dings are present on the face of the part.Device history record was reviewed and no discrepancies were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: on both images, there is glenosphere disassociation and resulting malalignment but no evidence of implant loosening.Bone quality is osteopenic on all images.There is malalignment on both exams secondary to glenosphere disassociation.No implant loosening, abnormal radiolucency, or other abnormality.There is glenosphere disassociation on both images, with very different position of the glenosphere on the 2 exams as noted.Polyethylene wear cannot be assessed on these images due to the disassociation.The root cause of the reported issue is attributed to use error, as the damaged baseplate was not replaced during the revision, leading to disassociation of the implants.Per instructions for use "biomet® comprehensive® reverse shoulder products" rev j: "inadequate preclosure cleaning (removal of surgical debris) can lead to excessive wear." the reported event is not confirmed, as the provided follow up x-rays are not dated.A summary of the investigation has been sent to the complainant.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: COMP RVRS 25MM BSPLT HA+ADPTR
• Common Device Name: SHOULDER, PROSTHESIS
• 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: 17169869
• Report Number: 0001825034-2023-01387
• Device Sequence Number: 7065637
• Product Code: KWS
• UDI-Device Identifier: 00880304531048
• UDI-Public: (01)00880304531048(17)291103(10)741600
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: 118000
• Device Catalogue Number: 010000589
• Device Lot Number: 564600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female