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

Model Number N/A

Device Problems Metal Shedding Debris (1804); Scratched Material (3020)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: unknown orthopedic salvage system axle, catalog#: 161035 lot#: 159990.Unknown orthopedic salvage system bearing, catalog#: unknown lot#: unknown.Unknown orthopedic salvage system femoral, catalog#: unknown lot#: unknown.Unknown orthopedic salvage system tibial tray, 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 yoke, catalog#: unknown lot#: unknown.Unknown orthopedic salvage system pin, catalog#: unknown lot#: unknown.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-11060, 0001825034-2018-00246, 0001825034-2018-00247, 0001825034-2018-00248.

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. 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 evalauation.

Event Description

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

• Brand Name: UNKNOWN ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL SEGMENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7186619
• MDR Text Key: 97120421
• Report Number: 0001825034-2018-00249
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• 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: 11/29/2018

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PROSTHESIS, KNEE; PROSTHESIS, KNEE
• Patient Outcome(s): Hospitalization; Required Intervention