MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEUTRAL ARCOM XL LINER; PROSTHESIS HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices - echo bi-metric lateralized femoral stem, # item 192112, lot: 923680; cocr modular heads, # item 163668, lot: j62500947; unknown cup, # item unk, lot: 6251955.(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08858, 0001825034-2018-08859 and 0001825034-2018-08861.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient experienced superficial infection less than a year post hip surgery and was treated with medication.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Udi - (b)(4).Concomitant medical products: unknown cup # item 010000666 lot 6251955.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: NEUTRAL ARCOM XL LINER
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7868099
• MDR Text Key: 119934640
• Report Number: 0001825034-2018-08860
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000734
• Device Lot Number: 6139237
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 96