MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 8; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 42521000510 63982344 articular surface fixed bearing; 42532007502 64019696 tibia cemented 5 degree stemmed right size f.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.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: 3007963827-2020-00131, 3007963827-2020-00133.

Event Description

It was reported that a clinical study patient underwent an initial right knee arthroplasty.Subsequently, patient experienced, stiffness, arthrolysis and was treated with movement under anesthesia approximately two years post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported patient underwent initial right total knee arthroplasty.Subsequently, the patient underwent a manipulation under anesthesia with cortisone treatment due to pain, swelling, and stiffness.After treatment, the patient¿s mobility improved for a short time but then symptoms returned.The patient underwent a revision of the articular surface with extensive arthrolysis due to arthrofibrosis approximately two years post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

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

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 8
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 10024257
• MDR Text Key: 189843960
• Report Number: 3007963827-2020-00132
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• 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: 42502606402
• Device Lot Number: 64082009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 65