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

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - foreign: (b)(6).The complainant has indicated that the product will be not be returned to zimmer biomet for investigation due to it still being implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.

Event Description

It was reported that during total knee arthroplasty while the surgeon was inserting a 10mm articular surface, the articular surface could not be inserted into the tibial base plate after several attempts.Subsequently, an 11mm articular surface was used to complete the procedure.There was no known impact or consequence to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Updated h10: 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 [mfr#: 3007963827 - 2021 - 00030 of art surface].

Event Description

Void.

• Brand Name: PERSONA 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
• MDR Report Key: 11322263
• MDR Text Key: 231639119
• Report Number: 3007963827-2021-00031
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

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: 64802947
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1