MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MLRY-HD LAT POR FMRL 9X150MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Nausea (1970); Pain (1994); Dizziness (2194); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Metal Related Pathology (4530)
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, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 163668, lot: 324300, 32mm mod head cocr -3mm neck.Part: 14-103654, lot: 651160, univ 2-hole shl 54mm lnr sz 24.Part: xl-105924, lot: 418200, arcomxl 32mm rlc lnr hw sz24.Part: 103536, lot: 027150, ti low profile screw 6.5x45mm.Report source- foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02756, 0001825034-2021-02761, 0001825034-2021-02762.
Event or Problem Description
It was reported the patient underwent a hip arthroplasty and subsequently 5 years later is experiencing pain, loss of balance, dizziness, elevated metal ions, difficulty in walking and upset stomach due to the deterioration and failure of implant.No revision has been reported at this time.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, b7, g3, h2, h3, h6 reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.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
It was reported the patient underwent a left hip arthroplasty and subsequently 5 years later is experiencing pain, loss of balance, dizziness, elevated metal ions, difficulty in walking and upset stomach due to the deterioration and failure of implant.No revision has been reported at this time.No additional information.

• Brand Name: MLRY-HD LAT POR FMRL 9X150MM
• 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: 12543324
• Report Number: 0001825034-2021-02726
• Device Sequence Number: 13809950
• Product Code: LPH
• UDI-Device Identifier: 00880304010253
• UDI-Public: (01)00880304010253(17)251028(10)831670
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2021

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: 10/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 11-104209
• Device Lot Number: 831670
• 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: 09/03/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male