MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED (PS) NARROW RIGHT SIZE 8; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Blood Loss (2597)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 42542007102 - tibia fixed non-porous right size e stem extension use required - 64454890; 42560613511 - stem extension 6mm offset splined - 64729222; 184704 - series a pat w/wr std 31 1 peg - 253500; 42522400710 - articular surface fixed bearing (ps) right 10 mm height - 64599858.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product is unavailable by hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a revision procedure approximately 15 days post implantation due to infection and wound dehiscence.The implants were removed and a static spacer was implanted as well as an im nail.Subsequently, the nail and spacer were removed and a competitor fusion nail was placed, due to a closed displaced comminuted fracture of shaft of right femur of unknown etiology.During the procedure the patient had an estimated blood loss of 1000 ml as a tourniquet could not be used due to the patient¿s thigh being too large for the cuff.The patient received 2 units of blood and also 250 ml of cell saver returned to patient.

Event Description

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: FEMUR CEMENTED POSTERIOR STABILIZED (PS) NARROW RIGHT SIZE 8
• 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: 10573018
• MDR Text Key: 208111652
• Report Number: 3007963827-2020-00231
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024228788
• UDI-Public: (01)00889024228788(17)280531(10)63947067
• Combination Product (y/n): N
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42500006402
• Device Lot Number: 63947067
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 106