MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-3; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Osteolysis (2377); Osteopenia/ Osteoporosis (2651)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: us157848 lot 920380 m2a cup 48x42mm, 157442 lot 207660 m2a head 42mm, 103203 lot 484280 taperloc femoral stem 9.0x137mm.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04895 head, 0001825034 - 2019 - 04897 cup, 0001825034 - 2019 - 04896 stem.
Event or Problem Description
It was reported that the patient had an initial right total hip arthroplasty and subsequently was revised nine years later due to increased pain and metal ion levels, as well as osteolysis and bone remodeling diagnosed on imaging.During the revision, thickening of the synovial tissue and local tissue reaction was noted.An extended trochanteric osteotomy was performed to remove the femoral stem, and a trochanteric plate with wires was required to stabilize the fixation due to erosion of the calcar.The head, neck, and stem were placed without further complication.Attempts were made to obtain additional information; however, none was available.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: M2A-MAGNUM 42-50MM TPR INSRT-3
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9631390
• Report Number: 0001825034-2020-00321
• Device Sequence Number: 502667
• Product Code: LPH
• UDI-Device Identifier: 00880304428027
• UDI-Public: 00880304428027
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K101336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 139254
• Device Lot Number: 221550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention