MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/02/2014

Event Type  Injury  

Manufacturer Narrative

The complaint product return was requested and not returned for evaluation.Review of dhr found no deviations or anomalies.Review of complaint history identified additional issues associated with this lot and item, no adverse trends noted.The root cause was not determined and the complaint was not confirmed.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Under possible adverse effects, number 4 states, ¿loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ following review, no new risks were identified.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2014-07866 and 0001825034-2017-07932.

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2014 due to acetabular loosening.During the procedure there was trouble disassociating the head from the stem, however, there was no delay as a result.The procedure was completed using competitor products.No additional patient consequences were reported.

• Brand Name: M2A-MAGNUM MOD HD SZ 46MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6916794
• MDR Text Key: 88264028
• Report Number: 0001825034-2017-07930
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 871790
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR