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

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/16/2019
Type of Reportable Event	Malfunction
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 underwent a pin and bushing revision to address severe pain.The device was identified loose upon clinical assessment.No further information is available at the time of this reporting.
Event or Problem Description
No further information 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.  the following sections were updated: b4; b5; d10; g4; g7; h1; h2; h3; h6 visual examination of the returned product identified ulna bushing is gouged and worn; accurate dimensional analysis not possible.Both humeral bushings are gouged and worn; accurate dimensional analysis not possible.Both the inner pin and outer pin have gouges and scratched.Inner pin prongs are bent but not fractured.Dimensions taken on inner and outer pin are confirming to print specifications.Unable to perform a compatibility check.Medical records were not provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: incomplete integration of bone on hardware in the distal humerus, possibly related to loosening, although this cannot be confirmed without comparisons to prior imaging, particularly the immediate postoperative image.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report 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: PIN/BUSHING REPLACEMENT KIT
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9378070
• Report Number: 0001822565-2019-05028
• Device Sequence Number: 3066572
• Product Code: JDC
• UDI-Device Identifier: 00889024508590
• UDI-Public: (01)00889024508590
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2020

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 Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 32810502501
• Device Lot Number: 62945969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2019
• Supplement Date Received by Manufacturer: 12/02/2019; 02/28/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/05/2019; 03/03/2020
• 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