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

Model Number	42-5220-006-10
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	05/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: tibia cemented 5 degree stemmed right size g catalog#42532007902, lot#64059128; all poly patella cemented 32 mm diameter catalog#42540000032, lot#64209107; femur cemented cruciate retaining (cr) narrow right size 10 catalog#42502006802, lot#62613524; palacos rg 1x40 single catalog#00111314001, lot#89624766.Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product has been discarded.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: 0001822565-2021-02710, 3007963827-2021-00205.
Event or Problem Description
It was reported that patient underwent an initial right total knee arthroplasty and was revised approximately 1.5 years later due to pain, increasing functional limitations, and instability.The components were found to be stable and well fixed.The stem, articular surface, and femur were exchanged with minimal bone loss and no complications.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; h2; h3; h6; h10.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.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: disabling pain and increasing functional limitations; clinical exam: mid-flexion and flexion instability; patella found stable; tibia was stable and appropriate alignment; minimal bone loss; labs: no infection.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 available at time of this report.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CR 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12514542
• Report Number: 3007963827-2021-00204
• Device Sequence Number: 17435563
• Product Code: MBH
• UDI-Device Identifier: 00889024241695
• UDI-Public: (01)00889024241695(10)230831(17)64125848
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 42-5220-006-10
• Device Catalogue Number: 42522000610
• Device Lot Number: 64125848
• 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: 09/02/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 118 KG