MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 5/6; PROSTHESIS, EXTREMITY

Catalog Number	00840009500
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Reaction (2414); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by mfr: device remains implanted.
Event or Problem Description
It was reported the patient suffered a fractured ulna as a result of a patient fall not related to any zimmer biomet device.Upon presenting for medical care, it was identified the patient had a metal allergy and a custom prosthesis has been requested.No device is available as the patient has not yet been revised.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as it was identified the patient had a known metal allergy.Dhr was reviewed and no discrepancies were found.Root cause is related to the patient condition.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
No further information is available at this time.

• Brand Name: ARTICULATION KIT SIZE 5/6
• Common Device Name: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8524096
• Report Number: 0001822565-2019-01547
• Device Sequence Number: 2689442
• Product Code: JDC
• UDI-Device Identifier: 00889024271463
• UDI-Public: 00889024271463
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K123862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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 Expiration Date: 03/31/2022
• Device Catalogue Number: 00840009500
• Device Lot Number: 63618395
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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: Other