MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D; PROSTHESIS, KNEE

Model Number 42-5320-067-01

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 07/14/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: articular surface fixed bearing posterior stabilized (ps) left 11 mm height: catalog#42512400511, lot#63857585; femur cemented posterior stabilized (ps) standard left size 8: catalog#42500606401, lot#63636841; all-poly patella cemented 29 mm diameter: catalog#42540200029, lot#63842186; cobalt hv bone cement 40g: catalog#402282, lot#288550; cobalt hv bone cement 40g: catalog#402282; lot#440420.Foreign: japan.Multiple mdr reports have been filed for this event.Please see associated reports: 3007963827-2022-00199; 3007963827-2022-00200; 0001825034-2022-01811; 0001825034-2022-01812.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial total knee arthroplasty.Approximately two years post-implantation, the patient started to experience pain in the knee.The products were ultimately revised four years and four months post initial implantation.During the surgery, the articular surface was found to be worn, the tibial component was found to have loosened and migrated, and the femoral component was loosened.The surgeon theorized that the loosening was caused by an inflammatory reaction to abrasion particles and cement technique error.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.It is alleged that the loosening is due to cementing technique error however without medical records a definitive root cause was unable to 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 Description

No further event information at time of this report.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D
• Type of Device: 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: 15190758
• MDR Text Key: 297508387
• Report Number: 3007963827-2022-00201
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024471030
• UDI-Public: (01)00889024471030(17)271031(10)63804253
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42-5320-067-01
• Device Catalogue Number: 42532006701
• Device Lot Number: 63804253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose