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

Model Number N/A

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

Patient Problems Local Reaction (2035); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unk item, unknown femoral stem, unk lot.Customer has indicated that the product will not be returned to zimmer biomet for investigation, location of product is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Kwon, y., rossi, d., macauliffe, j., peng, y., & arauz, p.(2018).Risk factors associated with early complications of revision surgery for head-neck taper corrosion in metal-on-polyethylene total hip arthroplasty.The journal of arthroplasty, 33(10), 3231-3237.Multiple mdr reports were filed for this event, please see associated reports:0001822565-2019-00558.

Event Description

It was reported in a journal article one patient was revised for symptomatic adverse local tissue reaction and elevated ion levels.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

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

It was reported in a journal article one patient was revised for symptomatic adverse local tissue reaction and elevated ion levels.Black metal debris was noted at femoral component trunnion neck taper and on the femoral head indicating corrosion.Patient required debridement of necrotic periarticular soft tissue, muscle, and bone secondary to altr from head- neck taper corrosion.Head was revised.

• Brand Name: UNKNOWN FEMORAL HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8320971
• MDR Text Key: 135540897
• Report Number: 0001822565-2019-00557
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention