MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT PRECOAT SIZE E LEFT PROSTHESIS, KNEE

Model Number N/A

Device Problems Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Swelling (2091); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00486. Concomitant medical devices: articular surface use with plate 3,4 size yellow/c-h 10 mm height, catalog#: 00595203010, lot#: 62066380; stemmed tibial component, catalog#: 00598003702, lot#: 62031439; stem extension replacement screw, catalog#: 00598009000, lot#: 62062312; taper stem plug, catalog#: 00596009900, lot#: 62036569; headed screw 48 mm length, catalog#: 00579104100, lot#: 62037223; headed screw 48 mm length, catalog#: 00579104100, lot#: 62037223; all poly patella size 32 mm dia. Standard 8. 5 mm thickness, catalog#: 00597206532, lot#: 62087178. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent left total knee arthroplasty. Subsequently, the patient was revised due to stiffness, pain, swelling, numbness, and audible noise.

• Brand Name: FEMORAL COMPONENT PRECOAT SIZE E 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
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8304800
• MDR Text Key: 134994771
• Report Number: 3007963827-2019-00033
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K071107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/05/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: N/A
• Device Catalogue Number: 00575001501
• Device LOT Number: 62042282
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/06/2012
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient TREATMENT DATA

Date Received: 02/05/2019 Patient Sequence Number: 1