MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR); PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Hyperextension (4523); Joint Laxity (4526)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 42502606202 - femoral component - 64218667.Report source: foreign - (b)(6).The customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 3007963827-2021-00211.
Event or Problem Description
It was reported that the patient underwent an initial knee arthroplasty.Approximately 2.5 years post implantation, the patient had a failed pcl resulting in instability and hyperextension.The surgeon attempted to revise the articular surface by changing to a uc.Upon trialing, hyperextension was not resolved.The surgeon decided to proceed with femoral revision.The cr component was removed and revised to a ps femur with cps articular surface.Attempts have been made and no further information has been provided.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant 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 not provided.It was mentioned that a failed pcl caused/contributed to the issue, however this cannot be confirmed.Therefore, a definitive root cause cannot be determined.Per the instructions for use, instability is a known adverse effect of the system.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 CRUCIATE RETAINING (CR)
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 12512703
• Report Number: 3007963827-2021-00212
• Device Sequence Number: 14744806
• Product Code: MBH
• UDI-Device Identifier: 00889024241558
• UDI-Public: (01)00889024241558(17)231130(10)64211860
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42522000410
• Device Lot Number: 64211860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 85