MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 13X150MM SPL TPR DIST; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Impaired Healing (2378)

Event Date 10/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of birth: unknown month and day in (b)(6).Concomitant medical products: catalog#: ep-200144 act artic e1 hip brg 28x38mm lot#: 645000.Catalog#: 110010242 g7 osseoti 3 hole shell 48mm c lot#: 6564825.Catalog#: 110024461 g7 dual mobility liner 38mm c lot#: 475980.Unknown head.Report source: foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted.The investigation is in process.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: 0001825034-2019-04861, 0001825034-2019-04866, 0001825034-2019-04867, 0001825034-2019-04869.

Event Description

It was reported that the patient underwent a wash out of the wound approximately one month post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

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.Concomitant medical products: catalog#: 110010242 g7 osseoti 3 hole shell 48mm c lot#: 6564825.Catalog#: 110024461 g7 dual mobility liner 38mm c lot#: 475980.Catalog#: ep-200144 act artic e1 hip brg 28x38mm lot#: 915380.Catalog#: 11-301300 arcos con sz a std 50mm lot#: 023440.

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.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression wound concerns or non-healing wound would imply that the appearance of the wound deviates from what a surgical wound should appear as.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.This deviation signifies an alteration in the wound healing process.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records will not be performed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARCOS 13X150MM SPL TPR DIST
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9247708
• MDR Text Key: 164078717
• Report Number: 0001825034-2019-04868
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2020

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: 11-300813
• Device Lot Number: 524980
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 12/09/2019; 03/26/2020
• Supplement Dates FDA Received: 12/20/2019; 03/30/2020
• 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
• Patient Age: 50 YR
• Patient Weight: 118