MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZIMMER UNICOMPARTMENTAL KNEE TIBIAL TRAY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 07/30/2022

Event Type  Injury  

Event Description

It was reported that one patient was revised eighty-one (81) months following unicondylar knee arthroplasty to address aseptic loosening.Attempts have been made, however, no additional information is available.

Manufacturer Narrative

(b)(4).Rossi, s.M.P., sangaletti, r., nesta, f., matascioli, l., terragnoli, f., benazzo, f.(30 jul 2022).A well performing medial fixed bearing uka with promising survivorship at 15 years.Archives of orthopaedic and trauma surgery 143(5), 2693-2699 https://doi.Org/10.1007/s00402-022-04562-7 b3 - date of article publication; the date of the incident is unknown d6a - all patients were implanted between jan 1, 2005 and dec 31, 2007 d10 - concomitant devices - unknown zimmer unicompartmental knee femoral component catalog #: ni lot #: ni, unknown zimmer unicompartmental knee articular surface catalog #: ni lot #: ni e1 - correspondence author g2 - report source - foreign: italy the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as additional information concerning each case cannot be released.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2023-01503 0001822565-2023-01504 h3 other text : insufficient information.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information provided.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: UNKNOWN ZIMMER UNICOMPARTMENTAL KNEE TIBIAL TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17074867
• MDR Text Key: 316668968
• Report Number: 0001822565-2023-01504
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose