MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problems Pain (1994); No Information (3190)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034-2018-10348, 0001825034-2018-10350.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) 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.Not returned to manufacturer.

Event Description

It was reported the patient underwent a metal-on-metal hip revision due to unknown reasons.No further information available.

Event Description

It was reported that a patient was revised approximately 15 years post implantation due to pain, elevated ion levels, metallosis, inflammation, and corrosion of the trunnion.Op notes indicated evidence of metal debris joint fluid, extensive corrosion of the trunnion, and evidence of superior acetabular erosion secondary to metal debris and inflammatory response.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This report is being submitted to relay additional information.Concomitant medical products: item # (b)(4), m2a 38mm mod hd , lot # unk; item # (b)(4), m2a 1 pc shell, lot # unk.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Op notes received for this revision noted evidence of metal debris in the fluid of the hip joint, extensive corrosion on the trunnion, and evidence of superior acetabular erosion secondary to metal debris and inflammatory response.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause remains undetermined.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: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8052578
• MDR Text Key: 126596477
• Report Number: 0001825034-2018-10349
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2019

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: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 11/15/2018; 04/04/2019
• Supplement Dates FDA Received: 12/12/2018; 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK PART/LOT HEAD, CUP; UNK PART/LOT HEAD, CUP
• Patient Outcome(s): Hospitalization; Required Intervention