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

Model Number N/A

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Local Reaction (2035); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 139252 ¿ m2a magnum taper ¿ unknown lot.11-103203 ¿ taperloc stem ¿ unknown lot.157442 ¿ m2a magnum head ¿ unknown lot.Customer has indicated that the product will not be returned to zimmer biomet 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: 0001825034-2020-02959, 0001825034-2020-02960.

Event Description

It was reported that patient underwent a right hip revision approximately 12 years post implantation due to in-vivo corrosion and osteolysis.Severe corrosion around the trunnion and significant metal changes around the metal on metal articular surface and soft tissues was noted.There was also significant osteolysis deep in the acetabulum.All components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable 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 stating there was severe corrosion around the trunnion and significant metal changes around the metal on metal articular surface and soft tissues.The stem and cup were removed without difficulty with minimal to no bone loss.There was significant osteolysis deep in the acetabulum and metal debris was also removed from the acetabulum.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause is unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03427.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 reported that patient underwent a right hip revision approximately 12 years post implantation due to in-vivo corrosion, osteolysis, altr and implant wear.All products were removed and replaced.Severe corrosion around the trunnion and significant metal changes around the metal on metal articular surface and soft tissues was noted.There was also significant osteolysis deep in the acetabulum.All components 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.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 event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3 visual inspection of the returned cup found scratching and discoloration on the inner radius.Debris is present on the inner radius near the rim.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.

• Brand Name: M2A-MAGNUM CUP
• 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: 10333552
• MDR Text Key: 200792451
• Report Number: 0001825034-2020-02958
• 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: 03/16/2022

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: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: US157848
• Device Lot Number: 744310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 09/02/2020; 02/09/2022; 03/14/2022
• Supplement Dates FDA Received: 09/03/2020; 03/07/2022; 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2007
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female