MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEUTRAL LINER 28 MM I.D. SIZE FF SIZE FF SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported when fixing this liner to the shell, the scallops were misaligned and fixed.Therefore, the surgeon removed this liner and used a backup liner.No additional information.
Additional Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause can be attributed to user error.A continuum trilogy liner was returned for evaluation.Visual evaluation identified the following: there was damage on the rim feature, anti-rotation tabs, and locking features.The damages on the anti-rotation tabs are indicative of a misaligned insertion.There is a hole running from the inner diameter to the backside surface, most likely a result of removal attempts.No other damages were noted.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 28 MM I.D. SIZE FF SIZE FF SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10671098
• Report Number: 0001822565-2020-03511
• Device Sequence Number: 14104755
• Product Code: OQG
• UDI-Device Identifier: 00889024154902
• UDI-Public: 00889024154902
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00885100728
• Device Lot Number: 64320598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 03/31/2021
• 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: ITEM: UNKNOWN UNKNOWN CUP LOT: UNKNOWN; ITEM: UNKNOWN UNKNOWN CUP LOT: UNKNOWN