MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISCOVERY FLANGED HUMERAL STEM - RIGHT; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Tissue Damage (2104)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 114813, disc ulna 3x75mm rt w/brng c, 580370.114700, disc condyle kit w/ hexalobula, 307490.(b)(6).Udi - (b)(4).The complaint is confirmed based on the pictures that were provided.Review of device history records found these units were released to distribution with no related deviations or anomalies.A definite root cause has not been determined at this time.Corrective action was initiated to further investigate root cause.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 Description

It was reported that during a total elbow arthroplasty procedure, it was discovered that screws that were not intended to be in the device following manufacturing, were found screwed into the device.The surgery was delayed, as the implant was already cemented in the patient and additional bone was required to be removed to implant a new component.No additional information is provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Only thread plugs were received.Implant was not returned.Examination of the returned thread plugs confirms the report.The thread plugs were meant to be removed during the manufacturing process.Investigation remains unchanged as previously reported.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 Description

No further information available.

• Brand Name: DISCOVERY FLANGED HUMERAL STEM - RIGHT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8000822
• MDR Text Key: 124861222
• Report Number: 0001825034-2018-08355
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K013042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 114905
• Device Lot Number: 521420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 11/21/2018
• Supplement Dates FDA Received: 11/27/2018
• 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