MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A STD 60MM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Wound Dehiscence (1154)

Event Date 09/08/2021

Event Type  Injury  

Event Description

It was reported that patient experienced wound dehiscence approximately 3 weeks after a hip revision.The patients wound was reopened and provided fluxocacilin oral.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Medical devices: 650-1157 ¿ delta ceramic head - 2020021127.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product 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 - 2022 - 02140, 0001825034 - 2022 - 02141, 0001825034 - 2022 - 02142, 0001825034 - 2022 - 02144.

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.It is noted in this complaint that there was wound dehiscence or reopening of the incision.An antibiotic was prescribed to prevent issues with infection while allowing the wound to heal as it ultimately did.This would be a common practice used to treat a non-healing incision site.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 additional event information to report at this time.

• Brand Name: ARCOS CON SZ A STD 60MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15420967
• MDR Text Key: 299927581
• Report Number: 0001825034-2022-02143
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304468030
• UDI-Public: (01)00880304468030(17)3004010(10)153020
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

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: 11-301301
• Device Lot Number: 153020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 10/31/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2020
• 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
• Treatment: SEE H10
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 60 KG