MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MAGNUM CUP 58 MM; PROSTHESIS HIP

Device Problems Material Erosion (1214); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part # unknown / unknown head / lot # unknown; part #unknown / unknown liner / lot # unknown; part #unknown / unknown stem/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00745.

Event Description

It was reported patient underwent left hip revision surgery approximately 12 years post implantation due to allegations of pain, elevated levels of cobalt and chromium, tissue deconstruction, bone deconstruction, and metal wear.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

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, h2, h3, h6 reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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 report 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 d10: item# unknown / m2a magnum 52 mm modular head / lot # unknown.Item # unknown / microbalance femoral stem /lot # unknown.Item # unknown / m2a magnum 52 taper adapter / lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -02968.0001825034 -2021 -02969.

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 the following sections were updated/corrected medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues for pain and discomfort in the hip, elevated chromium levels but no results included, osteolysis around the acetabulum, dark fluid, corrosion around the head/neck.No complications with the revision procedure.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 CUP 58 MM
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11504945
• MDR Text Key: 240349906
• Report Number: 0001825034-2021-00736
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR