MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS 60MM DST HML BDY LT; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Material Erosion (1214); Detachment of Device or Device Component (2907)

Patient Problem Local Reaction (2035)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 114700 disc condyle kit w/hexalobula, 054490; 130611 intramedullary plug 11-13mm, 804720; 114826 disc ulna 4x115mm lt w/brng c, 828090; 211224 compr srs ic seg - 30mm, 837690; 211236, compr srs mod stem - 8x100mm, 482580.The complaint is under investigation.Once the investigation is completed a follow up report will be submitted.

Event Description

It was reported that the patient underwent initial left elbow procedure and was subsequently revised due to unknown reasons.The patient has now undergone a revision procedure due to implant wear, disassociation and metallosis approximately seven (7) years post implantation.No additional information is available at this time.

Event Description

No additional information is available to report from the event.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history records identified no related deviations or anomalies during manufacturing.Root cause could not be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPR SRS 60MM DST HML BDY LT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8422483
• MDR Text Key: 138849684
• Report Number: 0001825034-2019-01102
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 211251
• Device Lot Number: 923660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 68