MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 60 MM O.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cat# lot# g2: foreign ¿ spain.The 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 approximately during surgery, the internal ring of the cup went out of its position.This prevented the liner from being fixed correctly.There was no known impact or consequences to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (5648920).
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (5648920).

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 60 MM O.D.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19751219
• Report Number: 0001822565-2024-02379
• Device Sequence Number: 15700151
• Product Code: LPH
• UDI-Device Identifier: 00889024118218
• UDI-Public: (01)00889024118218(17)241031(10)62819785
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 01/03/2025

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: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00620006022
• Device Lot Number: 62819785
• Was Device Available for Evaluation?: No
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2014
• 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
• Patient Sex: Unknown