MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW RIGHT SIZE 8; PROSTHESIS, KNEE

Model Number	42-5020-064-02
Medical Device Problem Codes	Osseointegration Problem (3003); Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial right knee procedure.Approximately eight months post implantation, the patient was revised for unknown reasons.During the surgery, it was observed that the polyethylene insert had pitting.All components were exchanged without complication.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: articular surface medial congruent (mc) right 10 mm height use with tibia sizes e-f/cr femur sizes 8-11, catalog#: 42522100810, lot#: 64427395.Tibia cemented 5 degree stemmed right size e, catalog#: 42532007102, lot#: 64786806.All poly patella cemented 32 mm diameter, catalog#: 42540000032, lot#: 64843526.Multiple mdr reports have been filed for this event, please see associated reports: 3007963827-2022-00034; 3007963827-2022-00037; 0002648920-2022-00027.Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 that a patient underwent an initial right knee procedure.Approximately five months post implantation, the patient began experiencing increasing pain.Three months later, the patient was revised due to painful aseptic loosening.During the revision, the tibial and femoral components were noted to be grossly loose with minimal ingrowth/cement adhering to the bone.The polyethylene insert was also noted to have pitting.The articular surface, tibial component, and femoral component were replaced without complication.The patellar button was well-fixed, stable, and left in place.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: a4; b1; b4; b5; b7; d9; d10; g3; h2; h3; h6; h10.D10: medical product: biomet bc r 1x40 us: catalog#110035368, lot#f2701z34ca, qty x2.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component (annex g) code is mechanical (g04) - femur.Visual examination of the returned tibial component identified signs of being implanted (scratched, wear, discolored).Foreign material was also found on the surface of the implant.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: office visit: presents with increasing severe pain, radiolucent line on the medial side of the tibial ap view; revision operational notes: grossly loose femoral and tibial implants, pitting of the poly, tibial and femoral components revised without complication 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: FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW RIGHT SIZE 8
• 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: 13474900
• Report Number: 3007963827-2022-00038
• Device Sequence Number: 14485395
• Product Code: MBH
• UDI-Device Identifier: 00889024229945
• UDI-Public: (01)00889024229945(17)300926(10)64807816
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 42-5020-064-02
• Device Catalogue Number: 42502006402
• Device Lot Number: 64807816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 02/18/2022; 05/31/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/09/2022; 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• 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.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 104 KG