MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS TRAY CO 44MM; SHOULDER, PROSTHESIS

Model Number	115370
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a primary reverse shoulder replacement and was subsequently revised due to dislocation, pain and implant fracture approximately five year post implantation.The surgeon discovered that the humeral tray had broken off its taper and the taper was stuck in the stem.The surgeon removed the tray/poly construct and the taper.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2023 -01440, 0001825034 -2023 -01442.D10: e1 44-36 std +3 hmrl brg cat: ep-115394 lot: 285150; comp rvrs shldr glnsp std 36mm cat: 115310 lot: 837020; comp primary stem 13mm mini cat: 113633 lot: 883710; comp aug mini bsplt w tpr lg cat: 110032430 lot: 64003004; comp rvs cntrl 6.5x35mm st/rst cat: 115397 lot: 572130; comp lk scr 3.5hex 4.75x25 st cat: 180552 lot: 603140; comp lk scr 3.5hex 4.75x25 st cat: 180552 lot: 651210; comp lk scr 3.5hex 4.75x30 st cat: 180553 lot: 237970; comp lk scr 3.5hex 4.75x30 st cat: 180553 lot: 851610.G2: foreign: australia.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were visual evaluation of the returned product identified that the taper of the tray has fractured.Dimensional analysis of the product determined that taper diameter, was conforming to print specifications.A small portion of the fractured taper was not returned.The returned device was reviewed using scanning electron microscopy.Fatigue mod of fracture identified in the non-smearing region with typical step-like fracture and fatigue striations in co-cr-mo alloy.Xrf analysis of the tray fracture showed that it was consistent with co-cr-mo alloy.Device history record was reviewed and no discrepancies were found.The reported event of implant fracture was confirmed through product return.The reported event of dislocation is unable to be confirmed.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 available at the time of this report.

• Brand Name: COMP RVS TRAY CO 44MM
• 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: 17219154
• Report Number: 0001825034-2023-01439
• Device Sequence Number: 20391506
• Product Code: KWS
• UDI-Device Identifier: 00880304543201
• UDI-Public: (01)00880304543201(17)280320(10)821480
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: 115370
• Device Catalogue Number: 115370
• Device Lot Number: 821480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male