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

Model Number N/A

Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)

Patient Problems Local Reaction (2035); No Code Available (3191)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: us157852 ¿ m2a magnum cup ¿ 854360; 139256 ¿ m2a magnum taper ¿ 021140; 103205 ¿ taperloc stem ¿ 976090.Customer has indicated that the product will not be returned for the 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01890, 0001825034 - 2020 - 01892, 0001825034 - 2020 - 01893.

Event Description

It was reported that patient underwent a left hip revision approximately 12 years post implantation due to metallosis and altr.During the revision, femoral osteolysis was noted as well as a retroverted acetabular cup behind which was significant bone loss.The stem remained intact while the cup and head were removed and replaced.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.Reported event was confirmed by review of medical records noting evidence of metallosis within the pericapsular structures posteriorly with dark clear fluid consistent with metal wear inflammatory response.The stem was well fixed with some proximal osteolysis.The cup was in a retroverted position and there was anterior wall loss as well as posterior wall loss.The patient required additional lengthening of the leg in order to gain adequate tension on the abductor sleeve and achieve stability of the hip.Shr 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.

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.Complaint sample was returned and evaluated against the reported event.The head has scuffing on the outside radius and there was no visible debris inside of the taper.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 HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10021226
• MDR Text Key: 193395345
• Report Number: 0001825034-2020-01891
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2021

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: 04/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 729900
• 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: 04/10/2020
• Initial Date FDA Received: 05/04/2020
• Supplement Dates Manufacturer Received: 07/10/2020; 03/19/2021
• Supplement Dates FDA Received: 07/15/2020; 03/23/2021
• 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