MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED POSTERIOR STABILIZED RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	42-5224-008-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	11/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent bilateral total knee replacements.Approximately four years and four months post implantation, the patient presented with generalized pain and swelling of the right knee.Subsequently, the patient underwent revision surgery of the articular surface during which a synovectomy was performed.Due diligence is in progress for this event; to date no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: femur cemented posterior stabilized (ps) narrow right size 11: catalog#: 42500007002, lot#: 63218099; tibia cemented 5 degree stemmed right size f: catalog#: 42532007502, lot#: 64113580; stem extension tapered cemented 14 mm diameter +30 mm length: catalog#: 42557000114, lot#: 64359049; all-poly patella cemented 35 mm diameter: catalog#4: 2540200035, lot#: 64270420; optip 80 refob plus bone cmt-3: catalog#: 4722502117-3, lot#: 808aa09228.Report source: foreign: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related 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: bilateral rom was 0-140.The op notes provided were incomplete and further information was unavailable.Root cause was unable to be determined.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 or Problem Description
No further event information at time of this report.

• Brand Name: ARTICULAR SURFACE FIXED POSTERIOR STABILIZED RIGHT 10 MM HEIGHT
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15885843
• Report Number: 3007963827-2022-00295
• Device Sequence Number: 5250283
• Product Code: MBH
• UDI-Device Identifier: 00889024243835
• UDI-Public: (01)00889024243835(17)221130(10)63857877
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: 11/30/2022
• Device Model Number: 42-5224-008-10
• Device Catalogue Number: 42522400810
• Device Lot Number: 63857877
• 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: 11/05/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 100 KG