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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: femur cemented cruciate retaining (cr) standard left size 9 catalog#: 42502606601 lot#: 64586950.Articular surface medial congruent (mc) left 10 mm height catalog#: 42512100910 lot#: 64478144.All poly patella cemented 38 mm diameter catalog#: 42540000038 lot#:64290049.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a during a left total knee arthroplasty, part of the tibial tray fractured and was retained in the bone.Attempts have been made and no further information has been provided.

Event Description

Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.This complaint has been reported under 0009617840-2021-00001.

Manufacturer Narrative

Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.This complaint has been reported under 0009617840-2021-00001.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE G
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 11133342
• MDR Text Key: 225590798
• Report Number: 3007963827-2021-00007
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K122765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532007901
• Device Lot Number: 64427162
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 107