MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE E 9 MM THICKNESS; PROSTHESIS, KNEE

Model Number	42-5282-005-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Damage to Ligament(s) (1952); Pain (1994); Swelling/ Edema (4577)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: partial femur cemented size 7 right medial: catalog#42558000702, lot#64616893; partial tibial cemented size e right medial: catalog#42538000502, lot#64830190.Report source: foreign: (b)(6).Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2022-00097; 0001825034-2022-00098.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 or Problem 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.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: partial femur cemented size 7 right medial: catalog#42558000702, lot#64616893; partial tibial cemented size e right medial: catalog#42538000502, lot#64830190.Report source: foreign: (b)(6).Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2022-00097; 0001825034-2022-00098.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 or Problem 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 or Problem 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.
Additional 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.
Additional 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 or Problem 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.
Event or Problem Description
No further event information at time of this report.
Additional 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.

• Brand Name: PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE E 9 MM THICKNESS
• Common Device Name: 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: 13283137
• Report Number: 0001825034-2022-00099
• Device Sequence Number: 20057628
• Product Code: HSX
• UDI-Device Identifier: 00880304818248
• UDI-Public: (01)00880304818248(17)250228(10)64660637
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/29/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 42-5282-005-09
• Device Catalogue Number: 42528200509
• Device Lot Number: 64660637
• 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: 12/23/2021
• Supplement Date Received by Manufacturer: 01/20/2022; 02/20/2022; 02/20/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/11/2022; 03/10/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 99 KG