MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM TAPER INSERT; PROSTHESIS , HIP

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problems Pain (1994); Tissue Damage (2104); Osteolysis (2377); Reaction (2414)

Event Date 01/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown m2a magnum head; unknown m2a magnum cup; unknown stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019-01739, 0001825034 -2019-01738, 0001825034 -2019-01736.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 due to osteolysis, metal poisoning and pseudotumor approximately 10 years post implantation.It was also reported that during the revision surgery, the modular neck was cold welded to the trunnion of the femoral component.Additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was confirmed by review of operative notes and x-rays.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: elevated metal ions & metallosis, metal on metal wear, pseudotumor, dark purplish thick fluid, and modular neck was cold welded onto the trunnion of femoral component.Osteolysis & pseudomembrane noted in proximal femur, bone graft used to fill in areas of osteolysis that was found in proximal femur dhr was reviewed and no discrepancies relevant to reported event were found.The additional information does not change the outcome 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

It was further reported in medical records that the patient was revised due to pain.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected one m2a-magnum mod hd sz 50mm was returned and evaluated.Upon visual inspection there is a dull line and scuffing on the outside radius and gouges to the face of the head.The insert has debris on the inside of the taper.The additional information does not change the outcome 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 further event information available at the time of this report.

• Brand Name: M2A-MAGNUM TAPER INSERT
• Type of Device: PROSTHESIS , HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8519796
• MDR Text Key: 142115141
• Report Number: 0001825034-2019-01737
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 139254
• Device Lot Number: 056160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2021
• 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
• Patient Age: 69 YR