MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 14X150MM SPL TPR DIST; COMMON DEVICE NAME

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

Patient Problem Pain (1994)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi# (b)(4).Concomitant medical products: catalog number:ep-200150 lot number:641560 brand name:act artic e1 hip brg, catalog number:163663 lot number:407210 brand name:28mm dia cocr mod hd, catalog number:11-300814 lot number: 130440 brand name:arcos 14x150mm spl catalog number:11-301302 lot number:615000 brand name:arcos con sz b std.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05088, 0001825034-2019-05089, 0001825034-2019-05090, 0001825034-2019-05091.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.Device remains implanted in the patient.

Event Description

It was reported that the patient was revised due to persistent left groin and buttock pain as well as proximal thigh pain on weight bearing approximately 2 years post implantation.During the revision, it was noted that the proximal body would not disengage from the distal stem resulting in leaving the stem implanted.Additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: a1; a5; g4; h2; h3; h6.Reported event was confirmed by review of medical records noting previous office visits where patient reports ongoing and persistent pain with no relief from injection.There are no notes however on the separation failure of the stem component.Dhr was reviewed and no discrepancies were found.The root cause is 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.

Event Description

No additional event information to report at this time.

• Brand Name: ARCOS 14X150MM SPL TPR DIST
• Type of Device: COMMON DEVICE NAME
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9309746
• MDR Text Key: 166389151
• Report Number: 0001825034-2019-05090
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-300814
• Device Lot Number: 130440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 78