MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE WITH LOCKING SCREW; KNEE PROSTHESIS

Catalog Number 00596203020

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/11/2016

Event Type  malfunction  

Event Description

It is reported that during knee arthroplasty the locking screw for implant fixation appeared to be too short and was not able to fix the articular surface implant properly.Another device was used to complete the surgery.

Manufacturer Narrative

The complaint sample was returned and the reported event was confirmed.Only the components from the kit were returned.Dimensional evaluation determined that the returned screw did not meet specifications of the labeled screw due to the wrong size screw packaged.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Potential root cause is identified to be gap in line clearance practices and will be further investigated for comingle issues that could not be identified during line clearance.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: NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE WITH LOCKING SCREW
• Type of Device: KNEE PROSTHESIS
• 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: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6085060
• MDR Text Key: 59345771
• Report Number: 0001822565-2016-03968
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK042271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 00596203020
• Device Lot Number: 62116977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2012
• 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