MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

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

Event Date 03/12/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of operative notes.Concomitant medical product- unknown taperloc stem catalog#:unk lot#:unk, unknown head catalog#:unk lot#:unk, unknown liner catalog#:unk lot#:unk.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of operative notes confirm that the patient underwent irrigation and debridement of left hip due to wound dehiscence distally and drainage.Upon entry, subcutaneous hematoma identified and evacuated.All nonviable appearing tissue debridement.Debridement did not extend into the fascia.Wound closed without further complication.Information included in the per form reported that intraoperative cultures were positive for gram positive cocci, staphylococcus,coagulase negative.This cannot be confirmed, however, as medical records or lab results that include this diagnosis were not provided.Root cause was unable to 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.Multiple mdr reports were filed for this event, please see associated reports:0001825034-2018-07681, 0001825034-2018-07696, 0001825034-2018-07737.

Event Description

It was reported that a patient initially underwent a total left hip arthroplasty.Patient presented 11 days post op with wound dehiscence distally and drainage.The patient underwent irrigation and debridement of the left hip due to non-healing surgical wound.No additional information is available.

• Brand Name: UNKNOWN CUP
• 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: 7767963
• MDR Text Key: 116596024
• Report Number: 0001825034-2018-07728
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 61