MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 BONEMASTER LTD ACET SHL 48C; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Impaired Healing (2378)

Event Date 05/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Concomitant medical products: part: unk, lot: unk, unk liner; part: unk, lot: unk, unk head; part: unk, lot: unk, unk stem.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02534; 0001825034-2021-02535; 0001825034-2021-02536.

Event Description

It was reported that patient underwent total hip arthroplasty and subsequently, 9 days post-implantation patient underwent re-operation and debridement due to delayed would healing.Attempts to obtain additional information have been made; however, no more is available at this time.

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.The reported deviation signifies an alteration in the wound healing process requiring surgical intervention.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.

• Brand Name: G7 BONEMASTER LTD ACET SHL 48C
• 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: 12393711
• MDR Text Key: 268999085
• Report Number: 0001825034-2021-02533
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K121874
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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: 010000701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2021
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 89 KG