MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED; PROSTHESIS, KNEE

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 42500606202 - femur cemented posterior stabilized (ps) standard right size 7 - 65174010.42532007102 - tibia cemented 5 degree stemmed right size e - 65425233.00597206529 - all poly petella standard cemented size 29 mm diameter 8.0 mm thickness - 65270006.3003940001-3 - refobacin bone cement r 1x40-3 - y25caf1002.Report source: foreign country : thailand.Customer has indicated that the product will not be 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 the patient underwent an initial knee surgery and the following day, the report of what products were used in the case was reviewed and it was identified that an articular surface of a mismatched size was used in this case.The packaging of the implant was correct.The patient had not experienced any complications postop, however, the surgeon decided that this mismatch would cause risks of instability and dislocation and that the patient should undergo a revision surgery to replace the articular surface with the correct size.The patient underwent a revision surgery one day later.There was no surgical delay.The surgical technique was utilized.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The root cause of the reported issue is attributed to user not following the instruction provided in the ifu which leads to user using incompatible implants.The ifu provided the compatible table.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15732405
• MDR Text Key: 303051788
• Report Number: 3007963827-2022-00282
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42521400410
• Device Lot Number: 65384815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose