MAUDE Adverse Event Report: ZIMMER GMBH ALLEGRETTO-TIBIAL PROSTHESIS; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Type  Injury  

Event Description

It was reported there was an implantation of medical surface replacement for the right knee joint in 2020.Approximately one year later, the patient experienced increasing pain on exertion; radiological dislocation and fracture of the tibial component was found.There is no information about a planned revision surgery.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).G2.Report source: germany.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.

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.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Due to insufficient product information, the compatibility of the involved products could not be verified.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were not provided.With the available information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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 Description

Diligence is complete and to date no further information is available.

• Brand Name: ALLEGRETTO-TIBIAL PROSTHESIS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18192259
• MDR Text Key: 328807452
• Report Number: 0009613350-2023-00646
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00889024427488
• UDI-Public: (01)00889024427488(17)221031(10)2928420
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 46.22.44-07
• Device Lot Number: 2928420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male