MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MAGNUM CUP; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Metal Shedding Debris (1804)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Metal Related Pathology (4530)
Date of Event	02/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: (b)(4), m2a-magnum modular head, (b)(4); (b)(4), m2a-magnum tpr insrt std, (b)(4); (b)(4), taperloc por lat fmrl, (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2016 - 04021.
Event or Problem Description
It was reported the patient underwent right hip revision approximately three years post-implantation due to pain, discomfort, and elevated metal ion levels.No further information is available at this time.
Additional Manufacturer Narrative
(b)(4).The reported event could not be confirmed based on limited information received.Product was not returned; therefore, the visual inspection could not be performed.Device history record  (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.Root cause could not be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 mdr reports were filed for this event, please see associated report: 0001825034-2016-04021.
Event or Problem Description
It was reported the patient underwent right hip revision approximately three years post-implantation due to pain, discomfort, and elevated metal ion levels.It was additionally reported that during the revision procedure metallosis with wear debris, trunnionis, and abductor muscle tear were identified.Mild discoloration was observed on the trunnion.Additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D6b: device remains implanted in the patient.One m2a-magnum mod hd sz 44mm and one m2a-magnum 42-50 tpr insrt std were returned and evaluated.Upon visual inspection the insert was installed in the head with the od of the head having a wear line.There is no visible debris inside of the taper.Medical records were reviewed which states the patient underwent a revision procedure due to failed hip replacement.Patient had abnormal cobalt chromium levels and pain.Metallosis with wear debris, trunnionis, and abductor muscle tear were identified during the procedure.Mild discoloration was observed on the trunnion.The acetabulum was stable without evidence of failure.The femoral head was replaced with ceramic head and e poly mobile bearing system.Patient tolerated the procedure well reported event was confirmed by review of medical records provided.Received additional information does not change the final conclusions of 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
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6806697
• Report Number: 0001825034-2017-06059
• Device Sequence Number: 101245
• Product Code: KWA
• UDI-Device Identifier: 00880304449435
• UDI-Public: (01)00880304449435(17)300623(10)702560
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: PK042037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2022

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: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: US157850
• Device Lot Number: 702560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 09/25/2017; 04/27/2022
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 09/26/2017; 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2013
• 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 Sex: Female