IMPLANT CEMENT BONE PALACOS (R) 1X40

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-31 for IMPLANT CEMENT BONE PALACOS (R) 1X40 manufactured by Zimmer, Inc..

MAUDE Entry Details

• Report Number: MW5090832
• MDR Report Key: 9266368
• Date Received: 2019-10-31
• Date of Report: 2019-10-31
• Date of Event: 2017-04-26
• Date Added to Maude: 2019-11-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: IMPLANT CEMENT BONE PALACOS (R) 1X40
• Generic Name: BONE CEMENT
• Product Code: LOD
• Date Received: 2019-10-31
• Lot Number: 85214571
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER, INC.

Device Sequence Number: 2

• Brand Name: IMP COMPONENT PATELLA CEMENTED 8X32MM POLY, CEMENTED
• Generic Name: PROSTHESIS, KNEE PATELLOFEMORAL, SEMI-CONSTRAINED
• Product Code: KRR
• Date Received: 2019-10-31
• Lot Number: 63634814
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ZIMMER, INC.

Device Sequence Number: 3

• Brand Name: KNEE IMPLANT
• Generic Name: PROSTHESIS, KNEE PATELLOFEMORAL, SEMI-CONSTRAINED
• Product Code: KRR
• Date Received: 2019-10-31
• Catalog Number: 42-5124-007-16
• Lot Number: 63052412
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: ZIMMER, INC.

Device Sequence Number: 4

• Brand Name: IMP BASEPLATE TIBIAL STEM SIZE E. 5 DEGREE
• Generic Name: PROSTHESIS, KNEE, PATELLOFEMORAL, SEMI-CONSTRAINED, MOBILBEARING
• Product Code: KRR
• Date Received: 2019-10-31
• Lot Number: 63548612
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: ZIMMER, INC.

Device Sequence Number: 5

• Brand Name: POST STABILIZER SIZE 8
• Generic Name: PROSTHESIS, KNEE PATELLOFEMORAL, SEMI-CONSTRAINED
• Product Code: KRR
• Date Received: 2019-10-31
• Catalog Number: 42-5000-064-01
• Lot Number: 63239722
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: ZIMMER INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit	2019-10-31