MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM G; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000666-g7 pps ltd acet shell 58g-6559818, 00877503602-bioloxâ® delta, ceramic femoral head-3001636, 574202075-avenir cmpl ha ho col size7.5-2991775.Multiple mdr reports were filed for this event, associated reports: 0001825034 -2020 - 03600.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.An i&d (incision & debridement) could be performed on the superficial non-healing wound.An i&d procedure can be used to promote the healing process, and this is a common procedure used to treat a non-healing incision site.As reported, the pts surgical site wound dehisced, his deviation signifies an alteration in the wound healing process and it was reported that medical intervention took place; however, it is unknown the specific type of intervention utilized.As also noted the patient also has several comorbidities: bmi is 46 and has sleep apnea which decreases oxygenation to the tissues which is important for healing.The patient is also noted to be tired/fatigued, often hungry/thirsty, blurry vision ¿ (possible signs/symptoms of diabetes), which can affect wound healing.(diabetes would require diagnosis by a physician or np).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 the patient had a wound dehiscence 1-month post implantation at the follow-up visit.The patient had an unknown medical intervention in the physician¿s office.Patient outcome was noted as tolerated.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: G7 NEUTRAL E1 LINER 36MM G
• 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: 10572308
• MDR Text Key: 208099138
• Report Number: 0001825034-2020-03601
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• 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: 010000859
• Device Lot Number: 6678484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 154