MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/H RADIAL 3-HOLE SHELL 58MM; PROSTHESIS, HIP

Catalog Number	12-104158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01417.G2: canada.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported a patient underwent a revision procedure for unknown reasons.The cup and liner were removed and replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information provided.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.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The returned shell has wear marks on the inner radius with bone debris on the outside diameter.Dhr was reviewed and no discrepancies related to the reported event were found.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.

• Brand Name: M/H RADIAL 3-HOLE SHELL 58MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17209212
• Report Number: 0001825034-2023-01418
• Device Sequence Number: 6074542
• Product Code: LZO
• UDI-Device Identifier: 00880304219878
• UDI-Public: (01)00880304219878(17)260201(10)719650
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K921181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Catalogue Number: 12-104158
• Device Lot Number: 719650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 10/26/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/07/2023; 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK LINER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown