MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NCBA, CANCELLOUS SCREW, 4.5 MM, FULLY THREADED, 40 MM; PROSTHESIS, EXTREMITIES

Catalog Number	0203159040
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02295.0001822565-2020-02298.Concomitant medical products: part# 00436004025 lot# 64464725.Part# 00436201500 lot# 64499689.Part# 00434904006 lot# 64287432.Part# 0203159030 lot# 64523530.Part# 0203150300 lot# 4502884436.Part# 0203150300 lot# 4502568205 product has been received by zimmer biomet and 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.
Event or Problem Description
It was reported patient underwent a shoulder revision approximately four (4) weeks ago due to a broken screw and loose components.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 9613350.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: NCBA, CANCELLOUS SCREW, 4.5 MM, FULLY THREADED, 40 MM
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10200903
• Report Number: 0001822565-2020-02297
• Device Sequence Number: 11030756
• Product Code: HWC
• UDI-Device Identifier: 00889024297135
• UDI-Public: (01)00889024297135
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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: 0203159040
• Device Lot Number: 64413211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 10/16/2020
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention