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

Model Number N/A

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the distributor the product arrived damaged with sterility barrier potentially compromised.There was no patient involvement.

Manufacturer Narrative

It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.

Event Description

It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.

• Brand Name: TIBIA CEMENTED STEMMED LEFT
• 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: 8584842
• MDR Text Key: 144272366
• Report Number: 3007963827-2019-00148
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532006701
• Device Lot Number: 64073757
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1