MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 50MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Tissue Damage (2104); Discomfort (2330); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 11-103205, taperloc por lat fmrl 11x142, 916780, us157856, m2a-magnum pf cup 56odx50id, 675670, 139252, m2a-magnum 42-50mm tpr insrt-6, 094660.

Event Description

It was reported that the patient underwent a revision procedure ten years post-implantation due to pain, discomfort, metallosis, and failure of the left hip implant.Attempts to obtain additional information have been made; however, no more is available.

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.Dhr was reviewed and no discrepancies 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and complaint sample evaluation.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.One m2a-magnum mod hd sz 50mm and m2a-magnum 42-50mm tpr insrt-6 were returned and evaluated.Upon visual inspection the lip of the returned head has scratching and the outside radius has dull spots in the finish.The insert has damage to the face and debris on the inside of the taper.Sem analysis: the taper of the returned device was reviewed via optical microscopy.It was discovered that there was damage over the majority of the surface with severe corrosion attack and abundant corrosion debris.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.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Review of medical records indicate that the patient was experiencing pain and elevated metal ions prior to surgery.Preoperative leg length discrepancy of 2cm.Large amount of hypertrophic synovitis with metallosis discoloration noted within the capsule.The connection sleeve was cold-welded to the stem taper and would not come loose after numerous attempts with a bone tamp¿large amount of corrosion on the taper.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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was further reported through patient's medical records that during the revision procedure, the surgeon noted a large amount of hypertrophic synovitis with metallosis discoloration.Further, there was a large amount of corrosion on the taper.

• Brand Name: M2A-MAGNUM MOD HD SZ 50MM
• 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: 6914242
• MDR Text Key: 88168388
• Report Number: 0001825034-2017-07479
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 157450
• Device Lot Number: 838780
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2007
• 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: 50 YR