MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET UNKNOWN ARCOMXL HI-WALL LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Cellulitis (1768)

Event Date 12/06/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 # unk, shell, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-05899, 0001825034-2018-05900, 0001825034-2018-05901.

Event Description

It was reported that approximately 6 weeks post implantation, the patient was noted to have developed cellulitis, requiring admission for antibiotic treatment.Attempts have been made and no further information has been provided.

Manufacturer Narrative

It was determined this device did not contribute to this event, the submission should be voided.Please void this reporting.

• Brand Name: BIOMET UNKNOWN ARCOMXL HI-WALL LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7767914
• MDR Text Key: 116596193
• Report Number: 0001825034-2018-05902
• Device Sequence Number: 1
• Product Code: LZO
• 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: 10/02/2018

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
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 09/07/2017
• Supplement Dates FDA Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 150