MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 56ODX50ID; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problems Pain (1994); Tissue Damage (2104); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown m2a head, unknown stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-00107.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to pain, bone destruction, metallosis and metal wear approximately 8 years post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of x-rays provided.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 failed left hip caused by adverse local reaction to metal on metal with multiple symptoms.During the procedure, pseudotumor was identified and excised.Pre-operative blood work showed that patient had elevated metal ions - cr at 12.7 and co at 16.3.Mri showed metal debris and adverse reaction.Adverse tissue reaction was found throughout the joint with neurolysis of left sciatic nerve.There was bone loss on the superior posterior aspect of the acetabulum.Osteolysis was noted at the anterior inferior portion of the acetabulum, posterior portion of the stem, and at greater trochanter.The cup and head were removed.The patient tolerated the procedure well 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.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: expiration date corrected.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.The following sections were updated/corrected updated: d9; g3; h2; h3; h6 an m2a-magnum pf cup 56odx50id, part # us157856 from lot 921710, was returned and evaluated against the complaint.Visual inspection found the inner radius of the cup to be mostly covered by a dried yellow-ish liquid.A few scratches were able to be observed on the inner radius.The half of the outer radius is covered in foreign debris.A portion of the coating has chipped away from the outer radius.Additional information provided does not change the root cause of the previous investigation.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 additional information on the reported event.

• Brand Name: M2A-MAGNUM PF CUP 56ODX50ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8258639
• MDR Text Key: 133459566
• Report Number: 0001825034-2019-00105
• 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,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/17/2021

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: 06/28/2019
• Device Model Number: N/A
• Device Catalogue Number: US157856
• Device Lot Number: 921710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 06/28/2019; 06/10/2021; 06/10/2021
• Supplement Dates FDA Received: 07/25/2019; 06/15/2021; 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention