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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Granuloma (1876); Impaired Healing (2378)

Event Date 05/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: item # unk, stem, lot # unk; item # unk, head, lot # unk; item # 010000661, shell, lot # 3024724; item # 010000847, liner, lot # 3117789; item # unk, unknown biolox delta option taper adapter, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08008, 0001825034 - 2018 - 08010, 0001825034 - 2018 - 07998, 0001825034 - 2018 - 07995, 0001825034 - 2018 - 08038.

Event Description

It was reported that a patient presented with wound drainage from a pin-hole ulceration.The patient was treated with antibiotics and local wound treatment.The wound continued to drain and the patient underwent an i&d with excision of granuloma.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).The follow-up report is being submitted to relay additional information.Reported event was considered confirmed by review of surgical notes.No product was returned; visual and dimensional evaluations could not be performed.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 wound.A definitive root cause cannot be determined with the information 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.

• Brand Name: BIOMET UNKNOWN BIOLOX HEAD
• 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: 7771744
• MDR Text Key: 116708466
• Report Number: 0001825034-2018-08039
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

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: 08/10/2018
• Supplement Dates Manufacturer Received: 09/14/2018
• Supplement Dates FDA Received: 09/26/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 136