MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 12MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 01/14/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a left knee arthroplasty revision to address worsening pain, increasing functional limitations and instability approximately one year post-operatively.Revision operative notes noted the patellar component was examined to be stable and remained implanted.Removal of the femoral and tibial components showed minimal bone loss.Appropriate range of motion, stability and patellar tracking were achieved with new components.No intraoperative complications were identified and the patient was transferred to recovery in stable condition.Attempts have been made, however, no additional information is available.

Manufacturer Narrative

(b)(4).Concomitant devices - persona posterior stabilized cemented narrow left size 8 catalog #: 42500006401 lot #: 64068776, persona cemented stemmed tibial component left size d catalog #: 42532006701 lot #: 64072823, persona tapered cemented stem extension 14mm catalog #: 42557000114 lot #: 64229084, persona cemented all poly patella 32mm catalog #: 42540000032 lot #: 64208861.The complainant has indicated that the product will not be returned to zimmer biomet for investigation as the devices were discarded.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2022-00165.

Manufacturer Narrative

Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2022-00165, 3007963827-2022-00166, 3007963827-2023-00085, 0001822565-2023-01003.

Event Description

It was reported that the patient underwent a left knee arthroplasty revision to address worsening pain, increasing functional limitations, swelling, component rotation, clicking noises and instability approximately one year post-operatively.Revision operative notes noted the patellar component was examined to be stable and remained implanted.Removal of the femoral and tibial components showed minimal bone loss.Appropriate range of motion, stability and patellar tracking were achieved with new components.No intraoperative complications were identified and the patient was transferred to recovery in stable condition.Attempts have been made, however, no additional information is available.

• Brand Name: PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 12MM
• 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: 14653316
• MDR Text Key: 293718684
• Report Number: 3007963827-2022-00166
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024237933
• UDI-Public: (01)00889024237933(17)230430(10)63996687
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123459
• 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
• Report Date: 04/12/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42512600512
• Device Lot Number: 63996687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• 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): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 110 KG