MAUDE Adverse Event Report: ZIMMER BONE DOUGH POLYMER; BONE CEMENT

Model Number 00110201200

Device Problems Device Slipped (1584); Failure to Align (2522)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 04/06/2016

Event Type  Injury  

Event Description

Cement bone dough polymer monomer liquid 20ml 40gm 1 sterile latex single serial no: (b)(4) model/cat no: (b)(4).Implant name: cement bone dough polymer monomer liquid 20ml 40gm 1 sterile latex single - log315068 laterality: left area: knee.Manufacturer: zimmer action: implanted number used: 2.Lot no: 62786332 exp date: (b)(6) 2017.Description: opened to field by (b)(6) at 1449.Inventory item: plate tib 62x41x2mm nexgen micro knee tivanium pmma uhmwpe precoat cement mod stem sterile.Sterile no: model/cat no.: (b)(4).Implant name: plate tib 62x41x2mm nexgen micro knee tivanium pmma uhmwpe precoat cement mod stem sterile - log315068.Laterality: left area: knee manufacturer: zimmer action: implanted number used: 1.Lot no: 63215865.Exp date: (b)(6) 2026.Description: operated to field by (b)(6), m at 1608.Inventory item: component fem d std knee lt cement option lps nexgen zimaloy sterile serial no: model/cat no: (b)(4).Implant name: component fem d std knee lt cement option lps nexgen zimaloy sterile - log315068.Laterality: left area: knee.Manufacturer: zimmer action: implanted number used: 1.Lot no: 62946321.Exp date: (b)(6) 2025.Description: opened to field by (b)(6), rn # (b)(4).Inventory item: component patellar std 8mm 29mm nexgen uhmwpe knee sterile blue grn yellow purple stripe.Serial no.: model/cat no: (b)(4).Implant name: component patellar std 8mm 29mm nexgen uhmwpe knee sterile blue grn yellow purple stripe - log315068.Laterality: left area: knee.Manufacturer: zimmer action: implanted number used: 1.Lot number: 63239960.Exp date: (b)(6) 2023.Description: opened to field by (b)(6), rn at (b)(6).Inventory item: insert articular 1-2 mm c-d 10mm knee net mold fix uhmwpe lps-flex nexgen sterile serial no: model/cat no: (b)(4).Implant name: insert articular 1-2mm c-d 10mm knee net mold fix uhmwpe lps-flex nexgen sterile - log315068.Laterality: left area: knee.Manufacturer: zimmer action: implanted number used: 1.Lot number: 63255305.Exp date: (b)(6) 2024.Description: opened to field by (b)(6), m.Implants.Tibial components loosening and misaligned.Severe pain, lack of rom and revised on (b)(6) 2018.

• Brand Name: BONE DOUGH POLYMER
• Type of Device: BONE CEMENT
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 7323150
• MDR Text Key: 102007538
• Report Number: MW5075744
• Device Sequence Number: 3
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/06/2018
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/30/2017
• Device Model Number: 00110201200
• Device Lot Number: 62786332
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 59