MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED PS STANDARD LEFT SIZE 9; PROSTHESIS, KNEE

Model Number	42-5006-066-01
Medical Device Problem Codes	Material Erosion (1214); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Local Reaction (2035); Metal Related Pathology (4530)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: articular surface fixed bearing cps left 10mm height: catalog#42512600510, lot#62916394; tibia cemented 5 degree stemmed left size d: catalog#42532006701, lot#63968974; stem extension tapered cemented 14 mm diameter +30 mm length: catalog#42557000114, lot#64069292.Report source: foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565-2021-02844, 3007963827-2021-00227.
Event or Problem Description
It was reported the patient underwent an initial left knee arthroplasty.Subsequently, patient felt a pop in the knee three weeks before the revision surgery.Patient was then revised 2 years and 9 months post implantation due to pain.Pre-revision images showed that the femur and tibia components were in contact with each other and the articular surface could not be seen.During the revision surgery, the articular surface was found to be broken into two pieces and no longer hinged onto the tibia locking mechanism.Patient¿s knee was also seen to have metallosis in the joint, and the femur and tibia implants both have visible wears.Patient was revised to a rotating hinge knee.It was reported that no further information is available.
Event or Problem Description
No further event information available at time of this report.
Additional Manufacturer Narrative
Visual inspection of the returned femoral component and provided pictures found it to exhibit signs of being implanted, gouged, and scratched with foreign material on the distal surface.Devices were submitted for further analysis.Analysis determined posterior overloading on the medial condyle, possibly exacerbated by misalignment between the bearing surface and femoral component, caused a crushing failure of the bearing surface, resulting in separation of the bearing surface from the tibial tray; the failure and separation of the bearing surface from the tibial tray allowed the bearing surface to shift towards the anterior of the knee and allowed metal-on-metal articulation between the femoral and tibial components, while partial articulation of the femoral on the bearing caused further damage to the bearing surface until the fracture was completed.Device history record was reviewed and no discrepancies related 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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: images demonstrate loss of joint space in both the medial and lateral compartments which is likely indicative of polyethylene wear.There is soft tissue swelling inferior to the inferior pole of the patella noted in the pre-revision images which could indicate injury to the patellar tendon, although this is not confirmed radiographically.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FEMUR CEMENTED PS STANDARD LEFT SIZE 9
• 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: 12556267
• Report Number: 3007963827-2021-00226
• Device Sequence Number: 11908194
• Product Code: JWH
• UDI-Device Identifier: 00889024229259
• UDI-Public: (01)00889024229259(17)260831(10)63437914
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 08/31/2026
• Device Model Number: 42-5006-066-01
• Device Catalogue Number: 42500606601
• Device Lot Number: 63437914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• 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: 09/10/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2016
• 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: Hospitalization; Required Intervention
• Patient Sex: Female