MAUDE Adverse Event Report: ZIMMER, INC. UNICOMPARTMENTAL KNEE SYSTEM TIBIAL COMPONENT PRECOAT SIZE 3 LT MEDIAL/RT LATERA; PROTHESIS, KNEE

Catalog Number 00584200301

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the inner sterile package was open.

Manufacturer Narrative

No product was returned; from the received photos it was noted that, there is a material transfer of outer box to tamper evident sticker and on tyvek cavity flange there is an adhesive which indicates that the tyvek lid could have been attached to the tyvek cavity flange.As it's unknown whether the tamper evident sticker was open or sealed when the customer received it, so it's unknown where the reported issue happened.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The risk of non sealed tyvek's or inner packaging is addressed in device's risk management file.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: UNICOMPARTMENTAL KNEE SYSTEM TIBIAL COMPONENT PRECOAT SIZE 3 LT MEDIAL/RT LATERA
• Type of Device: PROTHESIS, 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: 6341281
• MDR Text Key: 67805845
• Report Number: 0001822565-2017-00994
• 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: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00584200301
• Device Lot Number: 11017263
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1