MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEGMENT WITH MALE/FEMALE TAPER 30 MM LENGTH; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Bacterial Infection (1735)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00730, 0001822565-2019-00731, 0001822565-2019-00733, 0001822565-2019-00734, and 0001822565-2019-00735.Concomitant/ medical devices: distal femoral xt component size b right, catalog#: 00585004202, lot#: ni; segment with male/female taper 140 mm length, catalog#: 00585004614, lot#: ni; articular surface with segmental hinge post size b 12 mm height, catalog#: 00585002012, lot#: ni; tibial component precoat size 4, catalog#: 00588000400, lot#: ni; stem extension straight 18mm dia x 100mm length, catalog#: 00598801018, lot#: ni.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital would not release the devices.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 right knee arthroplasty.Subsequently, patient underwent irrigation, debridement, and replacement of components due to suspected infection and tibial loosening.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The product could not be evaluated and the reported event was not confirmed.The device history records could not be reviewed as the lot number associated with the reported event is unknown.Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the specified device caused any patient infection.However, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: SEGMENT WITH MALE/FEMALE TAPER 30 MM LENGTH
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8348351
• MDR Text Key: 136458326
• Report Number: 0001822565-2019-00732
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K070978
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• 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: 00585004603
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2019
• 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