MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOMXL 32MM RLC LNR HW SZ24 SZ 24; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Failure of Implant (1924); 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).Concomitant medical products: ref 14-103654 lot 705240 ringloc shell 54mm, ref 11-104209 lot 596070 mallory stem size 9, ref 163668 lot 343920 modular head 32mm-3, ref 103534 lot 175850 screw 6.5x35mm.Report source foreign: (b)(6).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 03487, 0001825034 - 2021 - 03489, 0001825034 - 2021 - 03490, 0001825034 - 2021 - 03491.
Event or Problem Description
It was reported the patient underwent an initial right total hip arthroplasty.The patient alleges that he experienced pain, loss of balance, dizziness and difficulty in walking and upset stomach due to the deterioration and failure of implant.Patient also alleges elevated ion levels.No revision has been reported at this time.No additional information.
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.Reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues legal summons line 15-16 patient alleges pain, loss of balance, elevated serum cobalt and chromium levels.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot 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: ARCOMXL 32MM RLC LNR HW SZ24 SZ 24
• 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: 13098237
• Report Number: 0001825034-2021-03488
• Device Sequence Number: 2007700
• Product Code: LPH
• UDI-Device Identifier: 00880304432468
• UDI-Public: (01)00880304432468(17)210316(10)403680
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042051
• 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): 04/04/2022

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: 03/16/2021
• Device Model Number: N/A
• Device Catalogue Number: XL-105924
• Device Lot Number: 403680
• 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: 12/03/2021
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2016
• 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: Other
• Patient Sex: Male