MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number 42-5380-005-02

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

Patient Problems Inflammation (1932); Damage to Ligament(s) (1952); Pain (1994); Swelling/ Edema (4577)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: partial femur cemented size 7 right medial: catalog#42558000702, lot#64616893; partial articular surface right medial size e 9 mm thickness: catalog#42528200509, lot#64660637.Report source: foreign: (b)(6).Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2022-00097; 0001825034-2022-00099.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported via a clinical study that a patient underwent an initial partial right knee procedure.During the trial reduction, the patient sustained an anterior cruciate ligament injury.The patient remained in the hospital for three days.At the time of this report, no additional medical intervention has been reported and the final outcome is unknown.Attempts have been made and no further information has been provided.

Event Description

It was reported via a clinical study that a patient underwent an initial partial right knee procedure.During a distal femoral osteotomy, the patient sustained an anterior cruciate ligament injury as a result of a saw blade injury.The injury was noticed later during trial reduction.The patient remained in the hospital for three days and received a corticosteroid injection at three months post op.Patient is noted as improving at six months and the injury is tolerated.All products remain implanted.A twelve month follow-up is pending.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported via a clinical study that a patient underwent an initial partial right knee procedure.During a distal femoral osteotomy, the patient sustained an anterior cruciate ligament injury as a result of a saw blade injury.The injury was noticed later during trial reduction.The patient remained in the hospital for three days and received a corticosteroid injection at three months post op for persistent pain and swelling.Patient is noted as improving at six months and the injury is tolerated with occasional pain.All products remain implanted.A twelve month follow-up is pending.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10.Visual and dimensional evaluations could not be performed as no product was returned nor were pictures provided.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device device history records will not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: partial acl injury when performing distal femoral osteotomy, hospital stay 3 days.Investigation results concluded that the reported event can be attributed to the intra-op complication and is not device related.An acl injury can cause pain, swelling, and make it difficult for a patient to bear weight and takes time to heal.Sources vary however an injury can take 6 to 9 months or longer to heal.The symptoms experienced by the patient following the known event are likely associated with the acl injury as the device has not been revised and the patient is slowly improving.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.H3 other text : see h10 narrative.

Event Description

No further event information at time of this report.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13283153
• MDR Text Key: 283967262
• Report Number: 0001825034-2022-00098
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304812697
• UDI-Public: (01)00880304812697(17)301022(10)64830190
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 42-5380-005-02
• Device Catalogue Number: 42538000502
• Device Lot Number: 64830190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 99 KG