MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: item number: 103202, item name: taperloc femoral stem, lot #: 894900; item number: 157850, item name: m2a-magnum cup, lot #: 481300; item number: 157444, item name: m2a-magnum head, lot #: 742780.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04868.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during a total hip revision the taper adaptor and stem would not disengage.During attempts to remove the taper adaptor from the stem the patient's bone fractured.Attempts have been made and no additional information is available.

Event Description

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

Manufacturer Narrative

Udi# (b)(4).Reported event was confirmed through revision operative notes received.Reported event was confirmed through revision operative notes received.At the time of the revision arthroplasty, the acetabular component was noted to be loose.The cold weld on the femoral head of the large bearing metal-metal could not be disengaged.With the extraction force greater than the patient's proximal osteoporotic bone, the stem extracted without separating the morse taper.This resulted in trochanteric and lesser trochanteric fractures and removal of posteromedial calcar bone with the stem.Review of the device history record identified no deviations or anomalies would contribute to reported event.A definitive root cause cannot be determined with the information 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: M2A-MAGNUM TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7778993
• MDR Text Key: 116995268
• Report Number: 0001825034-2018-04880
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 139256
• Device Lot Number: 327150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2019
• 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: 77 YR