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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00269.Medical products: item#: 00436303600, glenosphere centric 36 mm diameter +3 mm lateral , lot#: 64434604.Item#: 00434900613, tm reverse stem 6mm x 130mm, lot#: 64688201.Item#: 00434903603, poly liner plus 3 mm offset 36 mm diameter, lot#: 64287439.Item#: 47-4361-083-00, tm rvs tec reamer 1 blade, lot#: 56672653.Item#: 01.04223.048, invers/revers scr syst 4.5-48, lot#: unk.Item#: 01.04223.033, invers/revers scr syst 4.5-33, lot#: unk.Item#: 47430706100, cannulated drill with stop 6 mm, lot#: 64839174.Item#: 47430902501, pin 2.5 mm diameter, lot#: 64807554.Item#: 47430904601, drill 2.5 mm diameter, lot#: 64713568.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that patient underwent revision of shoulder procedure approximately two (2) months post implant due to glenosphere dissociating from the base plate.During procedure it was noted that only the glenosphere was explanted and replaced.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00269-1.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no (related) deviations or anomalies during manufacturing.Medical records were not provided.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.

• Brand Name: BASE PLATE UNCEMENTED 15 MM POST LENGTH
• Common Device Name: IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11262903
• Report Number: 0001822565-2021-00277
• Device Sequence Number: 16924306
• Product Code: KWS
• UDI-Device Identifier: 00889024489431
• UDI-Public: (01)00889024489431
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K172767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 00436201500
• Device Lot Number: 64465895
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDICAL PRODUCT: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR