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

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problem Local Reaction (2035)

Event Date 06/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products- unk microplasty size 5 std offset, unk zimmer trilogy cup size 50mm, unk longevity hxlpe liner size 32mm.Literature - risk factors associated with early complications of revision surgery for head-neck taper corrosion in metal-on-polyethylene tha,young-min kwon et.Al.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 a patient underwent revision surgery due to symptomatic altr and elevated cocr levels.Review of the journal article shows that there was black metal debris was noted at the femoral component trunnion neck and additionally the patient required debridement of varying degrees of necrotic periarticular soft tissue, muscle and bone.No additional information is available at this point of time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.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.

Event Description

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

• Brand Name: UNKNOWN COCR HEAD
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8330855
• MDR Text Key: 135862778
• Report Number: 0001822565-2019-00554
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• 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
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention