MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS); PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical products: femur cemented posterior stabilized (ps) catalog # 42500606202 lot # 63464345.Stem extension tapered cemented catalog # 42557000114 lot # 63522009; persona all poly patella catalog # 42540200032 lot # 63404724; persona stemmed 5-degree tibia catalog # 42532006702 lot # 63492613; palacos rg 1x40 single catalog # 00111314001 lot # 84094426; palacos rg 1x40 single catalog # 00111314001 lot # 82064447.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2022-00049.Product location is unknown.
Event or Problem Description
It was reported patient underwent a revision procedure five years post implantation due to due to arthrofibrosis and pain.During the revision dense scarring was found throughout the knee and flexion and extension mismatch.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).Medical products: femur cemented posterior stabilized (ps) catalog # 42500606202 lot # 63464345.Stem extension tapered cemented catalog # 42557000114 lot # 63522009; persona all poly patella catalog # 42540200032 lot # 63404724; persona stemmed 5-degree tibia catalog # 42532006702 lot # 63492613; palacos rg 1x40 single catalog # 00111314001 lot # 84094426; palacos rg 1x40 single catalog # 00111314001 lot # 82064447.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2022-00049.Product location is unknown.
Event or Problem Description
It was reported patient underwent a revision procedure five years post implantation due to due to arthrofibrosis and pain.During the revision dense scarring was found throughout the knee and flexion and extension mismatch.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates that the patient was presented with pain and arthrofibrosis.During the surgery, dense scar tissue was found.Debridement was performed with manipulation of knee 90 flexions.There was a flexion and extension mismatch due to arthrofibrosis, femoral revision was done to accommodate the mismatch.All component was well fixed and no complication was noted.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS)
• 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: 13584271
• Report Number: 0001822565-2022-00567
• Device Sequence Number: 14834487
• Product Code: MBH
• UDI-Device Identifier: 00889024243606
• UDI-Public: (01)00889024243606(17)210831(10)63454900
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42522400511
• Device Lot Number: 63454900
• 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: 02/11/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• 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 Sex: Female
• Patient Weight: 113 KG
• Patient Race: White