MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-6; PROSTEHSIS, HIP

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem Host-Tissue Reaction (1297)

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 180000, lot number: 249540, brand name: balance primary hip 7 x140 rt.Multiple mdr reports were filed for this event, please see associated reports 0001825034-2019-03240 medical records were provided and reviewed by a health care professional.Review of the available records identified that the patient underwent a revision procedure due to adverse reaction to metal debris from right metal on metal hip replacement.Surgeon removed the femoral head.However, it was difficult to disengage the femoral head from the stem.After removing the outer metal shell of the femoral head with a bone tamp, the ring was found to be fixed on the femoral stem tapper.A high speed diamond wheel was used to cut the ring and remove it.An active articulation construct and a biolox delta option ceramic head 28mm were used to complete the procedure.The patient tolerated the procedure well.Reported event was confirmed by review of medical records provided.Device history record was reviewed and no discrepancies were found.Root cause was 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.Device not returned for evaluation.

Event Description

It was reported that during revision surgery, the femoral head could not be removed.After removing the outer metal shell of the femoral head with a bone tamp, the ring was found to be fixed on the femoral stem tapper.A high speed diamond wheel was used to cut the ring.The ring then could be removed.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: M2A-MAGNUM 42-50MM TPR INSRT-6
• Type of Device: PROSTEHSIS, 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: 8831058
• MDR Text Key: 202710438
• Report Number: 0001825034-2019-03238
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 139252
• Device Lot Number: 841270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2008
• 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: 67 YR