MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 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).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2018 - 07447 ; 0001825034 - 2018 - 07449; 0001825034 - 2018 - 07455; 0001825034 - 2018 - 07456.Medical devices: lot number unk; 13-104158 shell, lot unk; unk part/lot, liner, femoral head, stem.Reported event was unable to be confirmed due to limited information received from the customer.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 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.Not returned to manufacturer.

Event Description

It was reported the patient had cellulitis requiring admission for antibiotic treatment post tha procedure.No further information is available.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: 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: 7765838
• MDR Text Key: 116527315
• Report Number: 0001825034-2018-07449
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• 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: 08/08/2018
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 150