MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER ELEVATED RIM 32 MM I.D. SIZE HH FOR USE WITH 50 MM O.D. SIZE HH SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown allofit cup, unknown head, unknown stem.Report source: foreign country: (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 that the liner of the allofit cup could not be seated into the cup despite being hit several times.The surgery was completed with a second liner.No adverse events have been reported as a result of the malfunction.No further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: LINER ELEVATED RIM 32 MM I.D. SIZE HH FOR USE WITH 50 MM O.D. SIZE HH SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10073149
• Report Number: 0001822565-2020-01787
• Device Sequence Number: 19757016
• Product Code: LPH
• UDI-Device Identifier: 00889024149694
• UDI-Public: (01)00889024149694
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151448
• 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): 08/20/2020

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00875200932
• Device Lot Number: 64467590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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