MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED CPS LEFT 12 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42512600712
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Ambulation or Postural Difficulties (2544); Osteopenia/ Osteoporosis (2651); Swelling/ Edema (4577)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Subsequently, two weeks post-implantation, the patient began to experience progressive pain and swelling of the left knee.Diagnostic images revealed a bone fracture of the distal femur.The patient underwent intervention to correct the fracture and the articular surface was found to be dislocated secondary to the fracture.The bearing was replaced without reported complication.Due diligence is in progress for this event, to date no further information has been reported.
Additional Manufacturer Narrative
(b)(4).D10: medical product: femur cemented posterior stabilized (ps) standard left size 7: catalog#42500606201, lot#65751325; tibia cemented 5 degree stemmed left size e: catalog#42532007101, lot#65967550; stem extension tapered cemented 14 mm diameter +30 mm length: catalog#42557000114, lot#65890790; all poly patella cemented 29 mm diameter: catalog#42540000029, lot#65800883; refobacin plus bone cem 2x40-3: catalog#3021170001-3, lot#ax30ce2303, qty#2; refobacin plus bone cem 2x20-3: catalog#3021180001-3, lot#x02aai0105 g2: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated report: 3007963827-2023-00327.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receipt of additional information, this device was determined to be not reportable.The previously reported dislocation was referring to the fractured bone fragments and not the articular surface.As the periprosthetic fracture was of the medial femoral condyle, only the implanted femoral component has been implicated in the reported event.The initial report for this device was forwarded in 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.
Event or Problem Description
Upon receipt of additional information, this device was determined to be not reportable.The previously reported dislocation was referring to the fractured bone fragments and not the articular surface.As the periprosthetic fracture was of the medial femoral condyle, only the implanted femoral component has been implicated in the reported event.The initial report for this device was forwarded in error.

• Brand Name: ARTICULAR SURFACE FIXED CPS LEFT 12 MM HEIGHT
• 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: 18366884
• Report Number: 3007963827-2023-00350
• Device Sequence Number: 7771393
• Product Code: MBH
• UDI-Device Identifier: 00889024238077
• UDI-Public: (01)00889024238077(17)280524(10)65842817
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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 Catalogue Number: 42512600712
• Device Lot Number: 65842817
• Was Device Available for Evaluation?: No
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Female