MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PIN/BUSHING REPLACEMENT; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330)
Date of Event	06/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up/final report will be submitted.Not returned to manufacturer.
Event or Problem Description
It was reported the patient was revised for a pin/bushing exchange due to unknown reasons.No further information is available at the time of this reporting.
Event or Problem Description
It was reported the patient underwent a pin and bushing revision to address pain and discomfort.No further information is available at the time of this reporting.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No device was returned for examination.Review of device history records was not possible as the necessary product/lot code combination was not provided.Root cause is unknown.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 the time of this reporting.
Event or Problem Description
No further information is available at the time of this reporting.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.Part/lot and subsequent manufacturing date and expiration date were originally reported incorrectly.The information is unknown.The investigation is in process.Once the investigation has been completed, a follow-up/final report will be submitted.

• Brand Name: UNKNOWN PIN/BUSHING REPLACEMENT
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9418136
• Report Number: 0001822565-2019-05130
• Device Sequence Number: 1725437
• Product Code: JDC
• UDI-Device Identifier: 00889024273924
• UDI-Public: 00889024273924
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K001989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/30/2020

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: 32810502501
• Device Lot Number: 62945969
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 12/17/2019; 01/29/2020; 01/29/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/27/2019; 01/30/2020; 01/30/2020
• 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
• Patient Weight: 102