MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE 15 MM POST LENGTH UNCEMENTED; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Failure to Osseointegrate (1863); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products:: 00434903611 64463135 glenosphere 36 mm diameter.0104211123 3015699 anatomical shoulderâ¿¢, humeral stem, cemented, 㸠12, 100 mm.0104223100 3032165 anatomical shoulderâ¿¢ reverse, humeral cup, 0â°, retro.Unk stem extremities impl.Foreign country: (b)(6).Reported event was confirmed by review of radiographs received.Review of the available records identified there is abnormal slightly increased spacing inferiorly between the base plate in the glenosphere when compared to the spacing more superiorly.This could be related to several possibilities, including but not limited to instability of the base plate (fracture as reported), improper integration of the hardware components, or improperly positioned components upon implantation.No radiographic signs of loosening.Remainder of the hardware appears intact and well integrated without periprosthetic lucencies.Bones are intact without fracture.Visual examination of the returned products identified the tm reverse shoulder base plate had damage on the taper, and the zimmer tm reverse shoulder glenosphere showed damage/scratches on the outer surface.The conical taper exhibited no damage.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 02885.
Event or Problem Description
It was reported patient underwent initial shoulder arthroplasty.Subsequently the patient was revised due to possible instability, disassociation, implant fracture and improper integration.During the removal, it was reported the glenoid had loosened or was improperly positioned.When the surgeon inserted the humeral plate, he had to use a lot of tension and strength.As a result, it may have happened that he used the levers to push the glenosphere back off.The base plate has also broken out.There was no mention of a traumatic event.In addition, the humeral shell could not be separated from the shaft.Cement got into the gap between the shaft and the cone.The cemented stem was explanted with the shell.Abnormal spacing is seen on x-rays received.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: BASE PLATE 15 MM POST LENGTH UNCEMENTED
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12598881
• Report Number: 0001822565-2021-02884
• Device Sequence Number: 17211116
• Product Code: KWS
• UDI-Device Identifier: 00889024268999
• UDI-Public: (01)00889024268999(17)291231(10)64612803
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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: N/A
• Device Catalogue Number: 00434901500
• Device Lot Number: 64612803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention