MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED LEFT 13 MM HEIGHT; PROSTHESIS, KNEE

Model Number 42-5124-007-13

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Event 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.

Manufacturer Narrative

(b)(4).D10: medical product: tibia cemented 5 degree stemmed left size e: catalog#: 42532007101, lot#: 64830726; femur cemented posterior stabilized (ps) standard left size 8: catalog#: 42500606401, lot#: 64686234; stem extension tapered cemented 14 mm diameter +30 mm length: catalog#: 42557000114, lot#: 65047538; 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; 3007963827-2023-00193; 0001822565-2023-01932; 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.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.The following sections have been 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.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 Description

No further event information at time of this report.

• Brand Name: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED LEFT 13 MM HEIGHT
• Type of Device: 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: 17350630
• MDR Text Key: 319376225
• Report Number: 3007963827-2023-00194
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024237278
• UDI-Public: (01)00889024237278(17)250531(10)64685963
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 42-5124-007-13
• Device Catalogue Number: 42512400713
• Device Lot Number: 64685963
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Sex: Female