MAUDE Adverse Event Report: ZIMMER, INC. SEGMENTAL ARTICULAR SURFACE SIZE B 26MM; PROSTHESIS, KNEE

Catalog Number 00585002026

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is completed, a follow-up mdr will be submitted.

Event Description

It was reported during a knee arthroplasty, the surgeon replaced the c trial and began to insert the size b 26mm implant.The surgeon realized that the insert was not the correct size as it was labeled to be and this caused a delay of one hour.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.Visual evaluation of the returned articular surface identified no cosmetic problem.Dimensional inspection found that the thickness at the lowest point of the condylar surface, the overall thickness, and the lateral width were all within tolerance.The antero-posterior width was found to be out of tolerance (larger than the maximum specified dimension) but the device was autoclaved prior to its return, which could have altered the dimensions.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.The size c 26mm trial and the size b 26mm final have the same thickness at the lowest point of the condylar surface, however, their overall thickness as well as the radii of curvature of the condylar surfaces are very different.The surgical technique clearly states to "insert the appropriate size articular surface provisional", when performing trial reduction.Therefore, it was concluded that user error is the root cause of the reported issue.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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: SEGMENTAL ARTICULAR SURFACE SIZE B 26MM
• 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: 6704875
• MDR Text Key: 79753186
• Report Number: 0001822565-2017-04710
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 00585002026
• Device Lot Number: 62614697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR