MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MAGNUM TAPER ADAPTER; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 04/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 mdr will be submitted.Concomitant medical products: modular taperloc femoral p/n 103201 l/n 590380.

Event Description

It was reported that during a hip revision, the taper adapter was difficult to remove from the trunnion due to cold welding.The femoral head and taper adapter had to be removed in segments.Evidence of metallosis was noted on the trunnion, which was irrigated and cleaned.No patient consequences were reported as a result.

Manufacturer Narrative

The initial medwatch submitted on may 23, 2017 should have had notification date apr 22, 2017.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.The initial medwatch submitted on may 23, 2017 should have had notification date apr 28, 2017.

• Brand Name: M2A MAGNUM TAPER ADAPTER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6585671
• MDR Text Key: 75779154
• Report Number: 0001825034-2017-03256
• 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: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 139258
• Device Lot Number: 317000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2009
• 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 Age: 49 YR