MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ELEVATED RIM LINER 32 MM I.D. SIZE II; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Joint Dislocation (2374)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: catalog number: 00875705201, lot number: 64531042, brand name: acetabular shell, catalog number: 00625006535, lot number: j6684866, brand name: bone screw, catalog number: 00625006520, lot number: 62963992, brand name: bone screw, catalog number: 00771100700, lot number: 64232501, brand name: m/l taper stem, catalog number: 00877503203, lot number: 3006376, brand name: biolox delta head.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.
Event or Problem Description
It was reported that the patient experienced anterior dislocation and underwent a closed reduction 2 days post implantation.Further, the patient experienced a second dislocation 21 days post-implantation and was reduced in the ed.Subsequently, the patient was revised due to subluxation, dislocation, pain, impingement, and clicking noise approximately 22 days post implantation.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  the following sections were  updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following : patient dislocated the right hip again when she was in bed and rolled over with her knee flexed.Another closed reduction procedure was performed.Revision notes identified impingement on the elevated poly liner with anterior dislocation.There is a very palpable click as the hip dislocates.The liner and the head were removed and replaced with new zimmer biomet products.No other complication/ findings related to the event were noted.Review of the radiographs identified the following : the patient's bone quality was osteopenic.Reported event was confirmed by review of medical records provided.Device history record 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.Actions, or field actions resulted after investigation of this event.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ELEVATED RIM LINER 32 MM I.D. SIZE II
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10158252
• Report Number: 0001822565-2020-02068
• Device Sequence Number: 3468215
• Product Code: OQG
• UDI-Device Identifier: 00889024155510
• UDI-Public: (01)00889024155510(17)230630(10)64030974
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00885201032
• Device Lot Number: 64030974
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 08/21/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 78