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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Necrosis (1971); Pain (1994); Impaired Healing (2378)

Event Date 11/25/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed as part number/lot number of device involved in the incident is unknown.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.Concomitant medical products: item # unk, head, lot # unk; item # unk, shell, lot # unk; item # unk, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05194, 0001825034 - 2018 - 05196, 0001825034 - 2018 - 05197.

Event Description

It was reported that approximately 3 weeks post implantation, the patient had presented with warmth and tenderness over the incision accompanied by pain and tenderness in the medial distal thigh.The incision had wound necrosis with no drainage.A week later, the wound developed blood drainage.Patient subsequently underwent irrigation and debridement due to non-healing surgical wound.The femoral head was revised and a hematoma was evacuated.A hemovac drain was also placed.Patient followed up with antibiotics and infectious disease physician.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of operative notes confirm that the patient underwent irrigation and debridement of the left total hip arthroplasty.(b)(6) male 3 1/2 weeks post primary left tha.Surgeon notes seen 1 week prior and noted no drainage, but edges of wound was necrotic.Wound started draining and elected to do i&d.Taken to surgery for i&d, excised necrotic wound edges, hematoma was noted and removed, sent for culture, 5000 wbc noted and surgeon states below the threshold for infection.No purulence, 5 deep specimens sent to lab.Hip was dislocated to allow for irrigation and head removed and replaced.Deep drain placed with primary closure.No complications noted.Plan was to keep patient for 48 hrs iv antibiotics as preventive measure and await cultures.Notes patient current smoker.It was stated in the per that organisms were isolated from the intra-operative broth sample, resulting in the diagnosis of infection.However, no medical records were received to confirm this diagnosis.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 STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7758115
• MDR Text Key: 116295660
• Report Number: 0001825034-2018-05195
• Device Sequence Number: 1
• Product Code: KWA
• 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: 08/21/2018

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: 08/21/2018
• 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: 68