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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign 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 the edge of the liner fractured while inserting into the shell.Another liner was used.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Upon reassessment of the reported event, the liner was determined to be not reportable and did not cause any harm or injury.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon reassessment of the reported event, the liner was determined to be not reportable and did not cause any harm or injury.Nor has this malfunction caused a previous serious injury.The initial report was forwarded in error and should be voided.

• Brand Name: NEUTRAL LINER 28 MM I.D. SIZE FF
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9626923
• Report Number: 0001822565-2020-00280
• Device Sequence Number: 2784447
• Product Code: LZO
• UDI-Device Identifier: 00889024154902
• UDI-Public: (01)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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

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: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00885100728
• Device Lot Number: 63830636
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 05/22/2020
• 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: UNKNOWN CUP.; UNKNOWN HEAD.; UNKNOWN STEM.