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

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Unstable (1667)

Patient Problems Granuloma (1876); Necrosis (1971); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown longevity liner ¿ unknown part and lot, unknown m/l taper ¿ unknown part and lot, unknown shell ¿ unknown part and lot, therapy date: unknown.Report source (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The reported event was identified during review of a journal article waterson, h.B., whitehouse, m.R., greidanus, n.V., garbuz, d.S., masri, b.A., & duncan, c.P.(2018).Revision for adverse local tissue reaction following metal-on-polyethylene total hip arthroplasty is associated with a high risk of early major complications.The bone & joint journal,100-b, 720-724.Doi:10.1302/0301-620x.100b6.Bjj-2017-1466.R1.

Event Description

It was reported that patient presented with instability and underwent a revision at an unknown amount of time post implantation.During the procedure, the joint was found to have developed adverse reaction to metal debris and revealed necrotic granulomatous and trunnionosis.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 (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 that patient presented with instability and underwent a revision at an unknown amount of time post implantation.During the procedure, the joint was found to have developed adverse reaction to metal debris and revealed necrotic granulomatous and trunnionosis.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNK HEAD
• Type of Device: PROSTHESIS, HIP
• 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: 7909996
• MDR Text Key: 121739220
• Report Number: 0001822565-2018-05250
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

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: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 10/31/2018
• 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