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

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Muscle/Tendon Damage (4532)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 42522100411 - articular surface medial congruent (mc) right 11 mm height use with tibia sizes c-d/cr femur sizes 6-7 - 64419211; 42532006402 - tibia cemented 5 degree stemmed right size c - 64367589; 42540000029 - all poly patella cemented 29 mm diameter - 64516079; 42557000114 - stem extension tapered cemented 14 mm diameter +30 mm length - 64458120.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00063.
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty and was subsequently revised approximately 15 months later due to an injury with pcl rupture with flexion instability.During the revision, the components were well fixed with laxity in flexion.The femur, stem, and polyethylene were exchanged without complications.The tibia and patella remained implanted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b6, b7, g3, g6, h2, h6, h10.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision approximately fifteen (15) months post-operatively to address a posterior cruciate ligament (pcl) rupture injury with flexion instability.During the revision, the components were noted to be well-fixed with laxity in flexion.Initial operative notes noted stability was achieved with the final components placed and there were no intraoperative complications.Revision operative notes noted femoral and articular surface instability.The patellar and tibial components were identified to be stable and left in place.The femoral and articular surface components were removed with minimal bone loss and stability was achieved with new components.No intraoperative complications were reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no complications were noted during the initial surgery.The patient underwent revision surgery for pcl tendon tear/rupture, and instability.Flexion was noted, however, all the component was well fixed.The surgery was completed with no issue.A definitive root cause cannot be determined.Per package insert, instability and poor range of motion are known adverse effects of the system.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Additional medical records were received and reviewed, which noted the patient was also experiencing pain with the previously reported adverse effects.Per the package insert for this system, pain is also a known adverse effect, however, the root cause remains undetermined at this time.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW RIGHT
• Common Device Name: 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: 13720890
• Report Number: 3007963827-2022-00062
• Device Sequence Number: 20304171
• Product Code: MBH
• UDI-Device Identifier: 00889024229907
• UDI-Public: (01)00889024229907(17)290630(10)64345579
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502006002
• Device Lot Number: 64345579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 04/05/2022; 06/03/2022; 07/01/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 04/05/2022; 06/29/2022; 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 70 KG