MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X38MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 02295, 0001825034 - 2019 - 02297.

Event Description

It was reported the patient underwent left hip revision surgery approximately 13 years post implantation due to dislocation which required a reduction.Subsequently, the patient underwent a second revision approximately 4 months after being revised, due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Udi# (b)(4).Reported event was confirmed with medical records/radiographs provided.Ultrasound performed due to left lower leg swelling and pain.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: ACT ARTIC E1 HIP BRG 28X38MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8635905
• MDR Text Key: 145925664
• Report Number: 0001825034-2019-02296
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2019

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 Expiration Date: 11/20/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-200144
• Device Lot Number: 155620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 04/29/2019; 08/13/2019
• Supplement Dates FDA Received: 05/23/2019; 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET HEAD, CAT#650-1055, LOT#215000; BIOMET M2A CUP, CAT#RD118848, LOT#740530; BIOMET STEM, CAT#11-104110, LOT#174210; BIOMET TAPER SLEEVE, CAT#650-1064, LOT#826580; BIOMET HEAD, CAT#650-1055, LOT#215000; BIOMET M2A CUP, CAT#RD118848, LOT#740530; BIOMET STEM, CAT#11-104110, LOT#174210; BIOMET TAPER SLEEVE, CAT#650-1064, LOT#826580
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 74