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

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the poly would not seat per technique.The surgeon could not get the poly to seat so he opened a new one of the same size and it was implanted with no issues.There was no consequences or impact to the patient.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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 the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: 42542006702 - tibia fixed cemented right size d stem extension use required - 64835319.42540000035 - all poly patella cemented 35 mm diameter - 65270980.42555803405 - tibial augment cemented half block right medial size cd 5 mm - 64353978.42545000510 - tibial central cone size x-small - 65034282.42555803205 - tibial augment cemented half block right lateral size cd 5 mm - 64333007.42560613513 - stem extension 6mm offset splined uncemented 13 mm diameter - 64739769.42560613514 - stem extension 6mm offset splined uncemented 14 mm diameter - 64876024.42556606605 - femoral distal augment cemented size 9, 9+ 5 mm thickness - 64614849.42556806605 - femoral posterior augment cemented size 9, 9+ 5 mm thickness - 65263702.42504606612 - femur cemented plus right size 9+ - 64287657.The following sections were updated: a2; b4; b5; d10; g3; g6; h1; h2; h10.This additional information does not change the previous investigation.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 the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned device found signs of use (nicked and gouged) and the dovetail feature is flared and compressed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for inserting the articular surface are provided in persona the personalized knee surgical technique.The root cause is attributed to use error.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.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED
• 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: 14022771
• Report Number: 3007963827-2022-00084
• Device Sequence Number: 2631919
• Product Code: MBH
• UDI-Device Identifier: 00889024244474
• UDI-Public: (01)00889024244474(17)261103(10)65206363
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42522600516
• Device Lot Number: 65206363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/22/2022
• Supplement Date Received by Manufacturer: 04/08/2022; 05/17/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 04/13/2022; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Sex: Female