MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X25MM ST/RST; PROSTHESIS, SHOULDER

Catalog Number	115395
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent left shoulder revision due to disassociation of the glenosphere from the baseplate.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).D10: cat: 010000589 lot: unknown ccomp rvrs 25mm bsplt ha+adptr.Cat: 110031418 lot: 66064982 cr prolong 36mm brng std.Cat: 115310 lot: j7633527 comp rvrs shldr glnsp std 36mm.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.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g3, g6, h1, h2, h3, h6, h11.The following section was corrected: h4.Reported event was confirmed by review of radiographs.Visual examination of the returned products identified a taper adaptor and screw were returned.There is some damage on the taper device; scuffs and scratches noticed on the morse taper and on the underside of the adaptor face, consistent with signs of implantation.Glenosphere remains attached.Associated bearing and humeral tray were also returned attached.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single view of the left shoulder demonstrates a reverse total shoulder arthroplasty with separation of the glenosphere from the baseplate.No dislocation.No fracture.No anatomical or other implant failures that would lead to a revision identified.  devices are used for treatment.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMP RVS CNTRL 6.5X25MM ST/RST
• Common Device Name: 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: 19354121
• Report Number: 0001825034-2024-01293
• Device Sequence Number: 7724503
• Product Code: KWS
• UDI-Device Identifier: 00880304677074
• UDI-Public: (01)00880304677074(17)331024(10)66350731
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 06/04/2024

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 Catalogue Number: 115395
• Device Lot Number: 66350731
• Was Device Available for Evaluation?: No
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/04/2024
• Date Device Manufactured: 10/24/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female