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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: item# 180553; lot# 267980; comp lk scr 3.5hex 4.75x30 st; item# 110032430; lot# 64143177; comp aug mini bsplt w tpr lg; item# 110030776; lot# 11024230; cr 40mm glenosphere std cocr.Foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01532, 0001825034-2021-01533.Product not returned.
Event or Problem Description
It was reported that the patient was revised due to broken screws that were holding the glenoid baseplate onto the bone which loosened the component.Attempts have been made and additional information on the reported event is unavailable.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs and visual examination of photographs.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to surgical use error as 4 screws should be used per the surgical procedure.A contributing factor was noted to be patient anatomy as it was stated only 2 peripheral screws were used due to glenoid anatomy excessively eroded and not enough bone for screw fixation anteriorly and posteriorly.Visual examination of the provided pictures could identify broken screws.Radiographs identified the following: fracture of the threaded screws from the glenosphere and base plate with displacement of the glenosphere and base plate superior to the glenoid.The glenosphere remains aligned with the humeral tray.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP RVS CNTRL 6.5X25MM ST/RST
• Common Device Name: EXTREMITIES, IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11848685
• Report Number: 0001825034-2021-01531
• Device Sequence Number: 14258861
• Product Code: KWS
• UDI-Device Identifier: 00880304677074
• UDI-Public: (01)00880304677074(17)290514(10)050670
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 115395
• Device Lot Number: 050670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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
• Patient Age: 81 YR
• Patient Weight: 80