MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXACT ALLIANCE BROACH/PROV14MM; INSTRUMENT, HIP

Catalog Number X31-400014

Device Problems Inadequacy of Device Shape and/or Size (1583); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00335.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that during the initial procedure the implant subsided past the level of resection.The surgeon had to remove and reprep the femur, a new implant was used and placed without any issues.Attempts have been made and no further information is available.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4; b5; d1; d2; d4; d9; g3; h2; h3; h4; h6.Corrected: b1.Proposed component code: mechanical (g04) ¿ rasp.B1: ¿adverse event¿ was selected in error.This event is only considered a ¿product problem¿.Visual examination of the returned product identified there is scuffing near the tapered threaded hole.There are indentations under the post.The overall length was checked and found in conformance to the print.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause is unable to be determined.The device evaluation found the product size to be conforming to specifications, therefor, this would not be considrered a reportable event.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: EXACT ALLIANCE BROACH/PROV14MM
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16389329
• MDR Text Key: 309742099
• Report Number: 0001825034-2023-00336
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: X31-400014
• Device Lot Number: 769030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Male