MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported that the plastic bottom of the tasp fractured upon insertion while being used for trialing during a procedure.No impact to patient was reported.

Manufacturer Narrative

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

It was further reported the event occurred during an initial total knee arthroplasty with previously implanted hardware.The instrument fractured in-situ, but all pieces were removed from the patient's wound.

Manufacturer Narrative

(b)(4).This report is being submitted to relay additional information.Udi # - (b)(4).Medical product: headless trocar drill pin, catalog #: 00590102000, lot #: 63932303.Patient specific bone model, catalog #: 00597000010, lot #: 56664996.Psi psn pin guides, catalog #: 00597000048, lot #: 56664995.Female screw, catalog #: 42509902525, lot #: 63970139.Femoral, catalog #: 42500606601, lot #: 63860625.Tibial stem, catalog #: 42532008301, lot #: 63560745.All poly patllea, catalog #: 42540000035, lot #: 63862292.Psn str hybrid st, catalog #: 42557000114, lot #: 63873062.Psn asf cps, catalog #: 42512600914, lot #: 63601942.Reported event was confirmed by review of photographs received.Device history record (dhr) was reviewed with no deviations identified.The review of supplier device history record was reviewed with one product non-confirmed affecting one part in operation 60 and thus scrapped.The root cause cannot 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.H3 other text : discarded, not returned to manufacturer.

Event Description

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

• Brand Name: CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7403725
• MDR Text Key: 104721987
• Report Number: 0001822565-2018-02053
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: PK123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42517600707
• Device Lot Number: 63693466
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention