MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER UNICOMPARTMENTAL TIBIAL COMPONENT PRECOAT SIZE 2 RIGHT MEDIAL/LEFT LATERA; PROSTHESIS, KNEE

Catalog Number 00584200202

Device Problems Component Missing (2306); Packaging Problem (3007)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 there was no product inside of the box.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Cmp-(b)(4).The following report is submitted to relay additional information updated: the reported event is confirmed.No products were returned; therefore, the visual and dimensional inspections were not performed.However, the photographs were reviewed and it was determined that the boxes were opened on the wrong end and shrink wrap was present and seemed to be broken.It was also noted that, the packaging material (cavities, poly wrap) and implant in shrink wrap were missing.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was determined to be due to a manufacturing deficiency.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: ZIMMER UNICOMPARTMENTAL TIBIAL COMPONENT PRECOAT SIZE 2 RIGHT MEDIAL/LEFT LATERA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6605205
• MDR Text Key: 76443387
• Report Number: 0001822565-2017-03776
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00584200202
• Device Lot Number: 63325472
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1