MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 6X24MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Catalog Number	11-210061
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 that patient underwent left elbow procedure on an unknown date 12 years ago.Subsequently, patient was revised 1 month ago due to unknown reasons.Patient was converted to total elbow.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d6; d11; g4; g7; h1; h2; h3; h4; h6.Corrected: d4.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02669.D4: udi should be blank as the udi number previously reported was not active at the time this device was manufactured.D11: part# 11-210045, lot# 949220.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: EXPLOR 6X24MM IMPL STEM W/SCR
• Common Device Name: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9726391
• Report Number: 0001825034-2020-00740
• Device Sequence Number: 19333321
• Product Code: KWI
• UDI-Device Identifier: 00880304210448
• UDI-Public: (01)00880304210448
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K040611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 07/07/2020

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 Expiration Date: 04/30/2018
• Device Catalogue Number: 11-210061
• Device Lot Number: 479850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention