MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 52ODX46ID; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to elevated metal ions, effusion and adverse local tissue reaction (altr) approximately 13 years post implantation.During the revision, an abductor tear and trochanteric bursa metal debris were noted.Metal debris noted to the posterior capsule and beneath the greater trochanter.The head and taper adapter were exchanged without complications.Femoral head trunnion had <20% area of dulling.The stem and cup remained implanted.It was noted the stability check showed no stability posteriorly and anteriorly.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant products: catalog number: 157446 lot number: 392910brand name: m2a-magnum mod hd.Catalog number: 139252 lot number:586290 brand name: m2a-magnum 42-50mm tpr insert.Catalog number:us157852 lot number:384970 brand name: m2a-magnum pf cup.Catalog number: 103201 lot number:657630 brand name: taperloc por fmrl 6.0x132.Multiple reports were submitted along with this report 0001825034-2022-00441, 0001825034-2022-00442.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: elevated metal ions, effusion on mri, local soft tissue reaction r/t metal debris.Trochanteric bursa removed d/t metal debris.Abductor tear repaired.Metal debris noted to the posterior capsule and beneath the grater trochanter.Femoral head removed and noted trunnion had <20% area of dulling, trunnion cleaned.Acetabulum with metal debris and cleaned with soft tissue to path.Reported event was confirmed by review of medical records provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Root cause could not 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.

• Brand Name: M2A-MAGNUM PF CUP 52ODX46ID
• Common Device Name: 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: 13666994
• Report Number: 0001825034-2022-00443
• Device Sequence Number: 14831822
• Product Code: KWA
• UDI-Device Identifier: 00880304449442
• UDI-Public: (01)00880304449442(17)310318(10)384970
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: US157852
• Device Lot Number: 384970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female