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

Model Number N/A

Device Problem Insufficient Information (3190)

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

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Unique identifier (udi) #: n/a.Concomitant medical products: item # unk, stem, lot # unk; item # unk, head, lot # unk; item # unk, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05090; 0001825034 - 2018 - 05091; 0001825034 - 2018 - 05093.

Event Description

It was reported that approximately one week post implantation, the patient had presented with a small opening of the surgical wound.The patient had attempted to treat the wound conservatively, but was unsuccessful.Subsequently, the patient underwent an irrigation and debridement due to non-healing wound with dehiscence.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Reported event can be confirmed by review of op notes.Op notes confirm that patient underwent i&d of r hip wound post tha.Patient reported 1 week post op removed dressing and noted small area open and treated wound herself.Wound progressed and contacted office, when surgeon recommended i&d.Taken to surgery, as surgeon started procedure, anesthesia reported potential ischemic changes and 12 lead ekg done.Minimal debridement done and no specimens collected, as patient was transferred to cardiac.Surgeon notes complication of mi during procedure.Information provided on per states that the patient was treated with antibiotics due to superficial wound infection, however, this cannot be confirmed as medical records state that the diagnosis was not provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

• Brand Name: BIOMET UNKNOWN SHELL
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7759276
• MDR Text Key: 116367746
• Report Number: 0001825034-2018-05092
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• 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
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 143