MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 11; PROSTHESIS, KNEE

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problems Hematoma (1884); Insufficient Information (4580)

Event Date 08/30/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: articular surface fixed bearing ultra congruent (uc) left 11 mm height, catalog#: 42512200611, lot#: 64024686.Tibia cemented 5 degree stemmed left size g, catalog#: 42532007901, lot#: 65349341.All poly patella cemented 41 mm diameter, catalog#: 42540000041, lot#: 65223568.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a left knee revision a day post-implantation due to a right femoral being implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04) - femur.Reported event was unable to be confirmed due to limited information received from the customer.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.The root cause of the reported issue is attributed to user error / off-label use due to a right femoral implant implanted into a left knee.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

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

Xit was reported that following a left knee arthroplasty, it was discovered from the implant records that the femoral implant used had been a right-oriented femoral component.The surgeon discussed this finding with the patient and recommended a revision procedure to exchange the femoral implant for a left-oriented one.The patient was revised one day post-operatively.Initial operative notes noted no intraoperative complications and there was no issue with the fit of any of the devices.Discharge notes noted the right size 11 femoral component was exchanged for a left size 11 femoral component one day post-operatively.Additionally, the patient had a large 200+ ml blood clot in the joint, which was evacuated during the revision.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: from discharge summary: "after completing the surgery, it was found that we were given a right size 11 femoral component rather than a left size 11 femoral component."; "the x-ray that was obtained postoperatively in the recovery room on close inspection, i could see there was a flare to the anterior flange of the femoral component".The root cause of the reported issue is attributed to user error / off-label use due to a right femoral implant implanted into a left knee.

Event Description

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

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, and h11.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision to remove right femoral implant and place a left femoral implant.No update to the previously reported root cause.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 11
• 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: 15463848
• MDR Text Key: 300376267
• Report Number: 3007963827-2022-00246
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024230446
• UDI-Public: (01)00889024230446(17)311210(10)65277548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 42502607002
• Device Lot Number: 65277548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 10/12/2022; 11/28/2023; 01/02/2024; 02/15/2024; 08/14/2024
• Supplement Dates FDA Received: 10/13/2022; 12/28/2023; 01/05/2024; 03/12/2024; 08/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2021
• 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: Male
• Patient Weight: 113 KG