MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure of the left hip due to a pseudotumor.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Cmp(b)(4).The device will not be returned for analysis, as patient has retained the device; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- head.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03192.Visual examination of the provided pictures identified a magnum construct that was explanted and are covered in bio-debris.No further evaluation can be made from the provided pictures.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 or Problem Description
Revision due to pseudo tumor.

• Brand Name: M2A-MAGNUM MOD HD SZ 46MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15600861
• Report Number: 0001822565-2022-02920
• Device Sequence Number: 2215587
• Product Code: KWA
• UDI-Device Identifier: 00889024572591
• UDI-Public: (01)00889024572591(17)250228(10)64515040
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 64515040
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• 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: CAT# 650-1055 BIOLOX HEAD LOT# 3087211.; CAT# 650-1068 TAPER SLEEVE LOT# 3063681.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female