MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ORTHOPEDIC SALVAGE SYSTEM YOKE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Scratched Material (3020)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown orthopedic salvage system axle, catalog#: 161035 lot#: 159990, unknown orthopedic salvage system femoral, catalog#: unknown lot#: unknown, unknown orthopedic salvage system tibial tray, catalog#: unknown lot#: unknown, unknown orthopedic salvage system other components, catalog#: unknown lot#: unknown, unknown orthopedic salvage system stem, catalog#: unknown lot#: unknown, unknown orthopedic salvage system femoral bushing, catalog#: unknown lot#: unknown, unknown orthopedic salvage system tibial bushing, catalog#: unknown lot#: unknown, unknown orthopedic salvage system pin, catalog#: unknown lot#: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-11060, 0001825034-2018-00246, 0001825034-2018-00247, 0001825034-2018-00248, 0001825034-2018-00249, 0001825034-2018-10943, 0001825034-2018-00246, 0001825034-2018-10944, 0001825034-2018-10945.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.Device not returned for evaluation.

Event Description

It was reported that the patient underwent revision surgery due to unknown reasons.The bearing, assembly, and diaphyseal segment were removed and replaced.It was noted by the surgeon that the axle had a scratch in the portion that makes contact with the yoke.The surgeon further noted that there were no product issues and that the patient¿s tissue was colored black around the prosthesis.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN ORTHOPEDIC SALVAGE SYSTEM YOKE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8116174
• MDR Text Key: 128792343
• Report Number: 0001825034-2018-10942
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• 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: KNE-OSS-YOKE-UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention