MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ULNAR STEM; ELBOW, ARTHROPLASTY

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Pain (1994); No Information (3190)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi # n/a.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2019 -01390.Patient not revised.

Event Description

It was reported patient has been indicated for elbow revision due to unknown reasons.No revision has been reported to date. attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that patient underwent elbow revision surgery fourteen years post initial surgery due to pain from loosening.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 event information available at the time of this report.

• Brand Name: UNKNOWN ULNAR STEM
• Type of Device: ELBOW, ARTHROPLASTY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8475088
• MDR Text Key: 140668787
• Report Number: 0001822565-2019-01389
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HUMERAL STEM; UNKNOWN HUMERAL STEM
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 70 YR