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

Model Number N/A

Device Problem Corroded (1131)

Patient Problem Reaction (2414)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: biomet m2a magnum taper cat#ni lot#ni, biomet m2a magnum head cat#ni lot#ni, biomet stem cat#ni lot#ni.Reported event was confirmed with medical records provided.Review of the available records identified the following: failed right tha secondary to metal hypersensitivity.Black/grey metallic debris was encountered and was debrided with care taken to limit damage to surrounding muscle and bone.Biomet magnum femoral head was disimpacted with care taken to protect trunnion.Modular head removed but adapter on the trunnion was not able to be removed and taper unable to be broken despite extensive effort in excess of 1 hour.Decision made to remove femur due to inability to remove taper.Metal debris noted adjacent to the cup.Competitor products placed.Noted to have satisfactory motion, stability and restoration.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot 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.Multiple reports are associated with this event; please see: 0001825034-2020-03262, 0001825034-2020-03263, 0001825034-2020-03261.

Event Description

It was reported the patient underwent a primary right tha on unknown date.Subsequently, the patient underwent a revision procedure due to metal related pathology.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: ref us157856 lot 663930 m2a cup.Ref 157450 lot 598640 m2a head.Ref 139254 lot 849220 m2a adapter.Ref 103205 lot 695640 taperloc femur.

Event Description

It was reported the patient underwent a primary right total hip arthroplasty.Subsequently, the patient underwent a revision procedure approximately 13 years later due to metal related pathology.All devices were explanted and competitor products were implanted.No further event information available at the time of this report.

Manufacturer Narrative

A review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.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 additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A m2a-magnum pf cup 56odx50id, part # us157856 from lot 663930, was returned and evaluated against the complaint.Visual inspection found scratching on the inner radius of the cup.The inner radius also exhibits dings and tool marks.Debris is affixed to the porous coating.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 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
• 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: 10547155
• MDR Text Key: 207366623
• Report Number: 0001825034-2020-03547
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/31/2022

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: 11/30/2016
• Device Model Number: N/A
• Device Catalogue Number: US157856
• Device Lot Number: 663930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 10/27/2021; 12/14/2021; 03/29/2022
• Supplement Dates FDA Received: 11/16/2021; 12/14/2021; 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2006
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male