MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS 3CM RESURFACING FEMORAL,RT; PROSTHESIS - KNEE

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Information (3190)

Event Date 06/16/2014

Event Type  malfunction  

Manufacturer Narrative

The product was implanted, and therefore is not available for return.Investigation results relayed to the sales rep via email.Without the opportunity to examine the complaint product, root cause cannot be determined.Review of device history records found units released for distribution with no deviation or anomaly.Review of complaint history found no additional issues reported for this lot.Review of complaint history found no additional issues reported for item: 150350 / lot: 665580 combination.No other issues reported for item: 150350 / complaint category: packaging : damaged sterile packaging combination.Inconclusive-root cause cannot be determined.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 revision procedure of competitor product on (b)(6) 2014, the right oss distal femur package was not sealed.It was also reported that a "biologic indicator" was used and the implant was then implanted.This procedure cause a 25 minute delay.

• Brand Name: OSS 3CM RESURFACING FEMORAL,RT
• Type of Device: PROSTHESIS - KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6907924
• MDR Text Key: 88169999
• Report Number: 0001825034-2017-07655
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PK002757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 150350
• Device Lot Number: 665580
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2013
• 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
• Patient Age: 58 YR