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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Cyst(s) (1800)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: s1s hip neck adapter std, pn 431186, ln 808850.Unknown space mold stem.Multiple mdr reports were filed for this event.Please see reports: 0001825034-2019-00372, 0001825034-2019-00374.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 evaluation.

Event Description

It was reported that an unexpected seroma formation was found post revision of spacer and femoral neck.Subsequently, patient underwent a procedure to drain the seroma.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

• Brand Name: UNK SPACER MOLD 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: 8569125
• MDR Text Key: 143697212
• Report Number: 0001825034-2019-01994
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK SPACER MOLD HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/01/2019
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention