MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M/L TAPER STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unk item #, unknown m/l taper stem, unk lot #; unk item #, unknown liner, unk lot #; unk item #, unknown ceramic head, unk lot #.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Taheriazam, a., & saeidinia, a.(2018).Short-term outcomes of one-stage bilateral total hip arthroplasty in young patients (orthopedic reviews, 10(2), 65-69.Doi:10.4081/or.2018.7542).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05227, 0001822565-2018-05228.

Event Description

It was reported in a journal article there were two patients who experienced a deep vein thrombosis post hip implantation that resolved with treatment.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).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 umber 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 there were two patients who experienced a deep vein thrombosis post hip implantation that resolved with treatment.No additional patient consequences were reported.

• Brand Name: UNKNOWN M/L TAPER STEM
• 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: 7906942
• MDR Text Key: 121635434
• Report Number: 0001822565-2018-05229
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/17/2018
• 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): Required Intervention