MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULATION KIT; PROSTHESIS, EXTREMITIES

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# 00840004510; lot# 63710101; humeral component plasma sprayed size 5 100 mm length.Item# 00840001407; lot# 63710294; ulnar component plasma sprayed size 4 75 mm length.Item# 00840009000; lot# 64093871; humeral screw kit 2 humeral screws.Item# 66017787; lot# 89444785; palacos lv + g (1x40.) report source - foreign: event occurred in (b)(6).Reported event was confirmed by review of medical records and x-rays which indicates premature loosening of humeral and ulnar left elbow prosthesis.Patient was presented with increasing load-dependent pain, complete loosening between the bone-cement interface as well as humeral and ulnar components.Visual examination of the returned product identified that the humeral and ulnar components contain large amounts of bone cement.The poly on the articulation kit components exhibit wear.Screw kit not returned.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmerbiomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00891, 0001822565-2020-00892.
Event or Problem Description
It was reported patient underwent a revision procedure approximately 14 months post-implantation due to suspected infection, loosening and pain.

• Brand Name: ARTICULATION KIT
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10420001
• Report Number: 0001822565-2020-02970
• Device Sequence Number: 14417885
• Product Code: JDC
• UDI-Device Identifier: 00889024271449
• UDI-Public: (01)00889024271449
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K123862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00840009500
• Device Lot Number: 64102160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/18/2020
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention