MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEM EXTENSION STRAIGHT 12MM DIA X 100MM LENGTH; PROSTHESIS, KNEE

Model Number	5988-10-12
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision right total knee arthroplasty.Approximately one year post implantation, the patient reported increasing pain.Upon x-ray review, the surgeon noted the tibia appears to have subsided with some radiolucent lines present suggesting loosening.The patient eventually underwent revision surgery one year and ten months post implantation due to aseptic loosening and subsidence of the tibial components.All components were revised.
Additional Manufacturer Narrative
(b)(4).This report was previously filed under an incorrect mfr number.Please see initial report: 0001822565-2020-01377.Concomitant medical products: stemmed tibial component precoat size 4 for cemented use only: catalog#00598003702, lot#64251672; tibial full block augment precoat size 4 10 mm thickness with 4 screws: catalog#00598800410, lot#64129884; all poly patella cemented 35 mm diameter: catalog#42540000035, lot#63586415; trabecular metal distal femoral augment block: catalog#00549003620, lot#64149270; trabecular metal distal femoral augment block: catalog#00549003610, lot#63911523; femoral component option for cemented use only size f right: catalog#00599401692, lot#63549024; articular surface with locking screw size striped yellow/e f 10 mm height: catalog#00599403210, lot#63765056; stem extension straight 14mm dia x 100mm length(combined length 145mm): catalog#00598801014, lot#64238386; palacos rg 1x40 single: catalog#00111314001, lot#87974718.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2020-01381; 0002648920-2022-00077; 0001822565-2022-00945.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- stem.Reported event was confirmed by review of medical records.Review of the available records identified the following: initial ops notes were not provided.Revision surgery was performed on (b)(6) 2019 for pain, loose femur & tibial component.Also, the tibial component was subsided.All the components were revised during the surgery without complication.(b)(6) 2020, the patient was present with pain and moderate effusion of the knee.The x-ray review identified no change in the femoral component position.But, the tibia plate was slightly subsided on the lateral view.It also states : additionally, the tip of the stem is closer to the lateral cortex of the tibia than on the immediate postoperative xrays which likely means loosening and migration.The radiolucency line will be continued to monitor.Device history record was reviewed and no discrepancies were found.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: STEM EXTENSION STRAIGHT 12MM DIA X 100MM LENGTH
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13976440
• Report Number: 0002648920-2022-00078
• Device Sequence Number: 17699677
• Product Code: JWH
• UDI-Device Identifier: 00889024220966
• UDI-Public: (01)00889024220966(17)280930(10)64158085
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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 Model Number: 5988-10-12
• Device Catalogue Number: 00598801012
• Device Lot Number: 64158085
• 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: 03/03/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2018
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 106 KG