MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: shell porous, cat#: 00620006022, lot#: 61340490.Femoral stem porous, cat#: 00671000701, lot#: 61272888.Biolox⮠option, head, s, 㸠36/-3.0, taper 12/14, catalog#: 00877703601, lot#: 2909489.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: 0002648920 - 2020 - 00381, 0001822565 - 2020 - 02979.
Event or Problem Description
It was reported by legal the patient was indicated for a revision approximately 2 years post implantation due to a follow up mri revealing large postoperative fluid.Attempts have been made and no further information has been provided.
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.The following sections were updated/corrected updated: a2, b4, b5, d4, g4, h2, h3, h4, h6 reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following : the patient underwent an initial left total hip arthroplasty due to osteoarthritis.Zimmer biomet components were implanted without complications.Subsequently, the patient underwent a revision procedure due to fluid collection around hip, pain, corrosion, elevated metal ions, and metallosis.The head and liner were replaced with new zimmer biomet devices without complications.A post revision follow up mri demonstrated a large left iliopsoas bursitis and large postop fluid collection along the left greater trochanter of the hip.No other complications/findings related to the event were noted.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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: LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10428775
• Report Number: 0001822565-2020-02980
• Device Sequence Number: 2186031
• Product Code: LPH
• UDI-Device Identifier: 00889024124868
• UDI-Public: (01)00889024124868(17)230331(10)63964841
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K002960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00631006036
• Device Lot Number: 63964841
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other