MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-3; PROSTHESIS, HIP

Catalog Number 139254

Device Problems Corroded (1131); Difficult or Delayed Separation (4044)

Patient Problems Host-Tissue Reaction (1297); Erosion (1750); Necrosis (1971); Pain (1994); Tissue Damage (2104); Reaction (2414)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: us157852-m2a-magnum pf cup-478990, 157446-m2a-magnum mod hd-805470, 11-103208-taperloc por lat fmrl-860090.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05561, 0001825034 - 2019 - 05563, 0001825034 - 2019 - 05580.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial left hip arthroplasty on.Subsequently, the patient presented to physician 9 years¿ post-op for an mri.The patient then underwent a revision surgery about 1 month later due to pain, tissue destruction, bone destruction, metal wear, metal poisoning, loss of enjoyment of life, limited of daily activities, adverse local tissue reaction and abductor necrosis.During the surgery, large amounts of purulent fluid was noted and destruction of the abductor mechanism.The femoral head could not be disimpacted.Corrosion was noted on the trunnion.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d11; g4; h2; h3; h6.D11: 11-103208 ¿ taperloc stem ¿ 860090.Reported event was unable to be confirmed due to limited information received by the customer.Dhr was reviewed and no discrepancies were found.The root cause is 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.

• Brand Name: M2A-MAGNUM 42-50MM TPR INSRT-3
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9476829
• MDR Text Key: 176756624
• Report Number: 0001825034-2019-05564
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 139254
• Device Lot Number: 520190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention