MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 11 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Erosion (1214); Pitted (1460)

Patient Problem Failure of Implant (1924)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00100, and 3007963827-2022-00101.Concomitant medical products: medical devices: femur cemented cruciate retaining (cr) narrow right size 11 catalog#: 42502007002 lot#: 63945508.Tibia cemented 5 degree stemmed right size e catalog#: 42532007102, lot#: 64663912.All poly patella cemented 32 mm diameter catalog#: 42540000032, lot#: 64620984.Palacos r (1x40) catalog#: 66017778 lot#: 92384711.Palacos r (1x40) catalog#: 66017778, lot#: 92384711.Customer has indicated that the product is in process of being 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 patient underwent a right knee revision approximately fourteen months post-implantation due to pain, loosening, and a titanium allergy.During the revision, the articular surface was found to pitted and bubbled.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h10.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned articular surface identified signs of being implanted (nicked/gouged) and has foreign material attached.The returned implant also shows signs of pitting and wear.Device history record was reviewed and no discrepancies were found.Review of complaint history found no additional related issues for this items and the reported part and lot combination.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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.

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 11 MM HEIGHT
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14166154
• MDR Text Key: 289730203
• Report Number: 3007963827-2022-00099
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024468429
• UDI-Public: (01)00889024468429(17)250630(10)64783880
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K150090
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• 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: 42522100811
• Device Lot Number: 64783880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• 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 Outcome(s): Required Intervention; Hospitalization