MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEUTRAL LINER 36 MM I.D. SIZE NN FOR USE WITH 62 MM O.D. SIZE NN SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00784801200- modular neck e 12/14 neck taper use with +0 heads only- 63330666.00877503602- biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14- 2838136.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02602.Customer has indicated that the product will not be returned to zimmer biomet for investigation, not returned by hospital.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 patient underwent a left hip revision approximately 4 years post implantation due to instability with subsequent dislocations.During the procedure a longer and more offset kinectiv neck and elevated lip liner were used.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Photographs of the explanted products were provided.Visual review identified the following: the products were covered in bio debris.There was discoloration on the head's taper surface.No further evaluation could be performed with the images provided.Review of the device history records identified no deviations or anomalies during manufacturing.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEUTRAL LINER 36 MM I.D. SIZE NN FOR USE WITH 62 MM O.D. SIZE NN SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10296274
• Report Number: 0001822565-2020-02601
• Device Sequence Number: 3178481
• Product Code: OQG
• UDI-Device Identifier: 00889024155152
• UDI-Public: (01)00889024155152
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K120370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 00885101536
• Device Lot Number: 63303250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 125