MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN INSTRUMENT ELBOW, ARTHROPLASTY

Model Number N/A

Device Problem Unclear Information (4052)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Udi # n/a. Report source: foreign country: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon could not get the reduction tool instrument in between the ulna and the ulna component to be able to use the tool. Hence, surgeon used tamps. But, due to the use of tamps, poly was damaged and the screws could not seat. Hence, surgeon had to revise the articulation kit.

Manufacturer Narrative

(b)(4). This follow-up report is being submitted to relay additional and/or corrected 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. 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 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 INSTRUMENT
• Type of Device: ELBOW, ARTHROPLASTY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8350528
• MDR Text Key: 136510699
• Report Number: 0001822565-2019-00774
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 02/19/2019 Patient Sequence Number: 1

Treatment

00840009500, ARTICULATION KIT, 63820028; 00840009500, ARTICULATION KIT, 63820028