MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED STANDARD LEFT SIZE 8; PROSTHESIS, KNEE

Model Number	42-5006-064-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Subsequently, over two (2) years post-implantation, the patient is experiencing pain, swelling, stiffness, and trouble walking with the left knee.No additional medical intervention has been reported.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
(b)(4).D10: medical product: tibia cemented 5 degree stemmed left size e: catalog#42532007101, lot#64830726; stem extension tapered cemented 14 mm diameter +30 mm length: catalog#42557000114, lot#65047538; articular surface fixed bearing posterior stabilized (ps) left 13 mm height: catalog#42512400713, lot#64685963; all poly patella cemented 32 mm diameter: catalog#42540000032, lot#64843550; bone scr 6.5x30 self-tap: catalog#00625006530, lot#64945771; bone scr 6.5x30 self-tap: catalog#00625006530, lot#j6982649; biomet bc r 1x40 us: catalog#110035368, lot#k1904z34sa.Multiple mdr reports have been filed for this event, please see associated reports: 3007963827-2023-00192; 0001822565-2023-01932; 3007963827-2023-00194; 0002648920-2023-00163.The product will not be returned to zimmer biomet for evaluation as the product remains implanted.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
Additional Manufacturer Narrative
This follow up report is being submitted to relay additional information.Proposed component code: mechanical (g04) - femur.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.Root cause was unable to be determined.Complaint cannot be confirmed.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 POSTERIOR STABILIZED STANDARD LEFT 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17350475
• Report Number: 3007963827-2023-00193
• Device Sequence Number: 5466924
• Product Code: JWH
• UDI-Device Identifier: 00889024229235
• UDI-Public: (01)00889024229235(17)300531(10)64686234
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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 Model Number: 42-5006-064-01
• Device Catalogue Number: 42500606401
• Device Lot Number: 64686234
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2020
• 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: Other
• Patient Sex: Female