MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 50MM O.D. SIZE HH POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH HH LINERS; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 00875200932 item name 32mm i.D.Size hh elevated rim liner use with 50mm o.D.Size hh shell lot # 65578593 g2: foreign: india visual examination of the provided pictures identified the liner and shell being held together by the surgeon.A video shows the surgeon attempting to assemble the liner and shell on the table, however the liner can be easily separated after impaction.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.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.H3 other text : device location is unknown.
Event or Problem Description
It was reported that the liner would not seat in the cup.They attempted to seat it for 3 hours when they finally concluded that the procedure needed to be completed using new devices.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified upon return the liner was seated in the shell.The liner shows gouges and indentations on the high wall rim, inner spherical surface, as well as the face where the item etch is located.The shell shows scratches on the rim face.Multiple gouges are noted on the rim face that are near or under the lip of the high wall of the liner.No other damage is noted.During evaluation the liner was found to be firmly seated in the shell with no movement.The anti rotation scallops are flush in the shell as intended.The high wall lip of the liner is fully seated against the shell face as intended.Root cause unchanged.This complaint cannot be confirmed.The devices were returned seated together.A previous video showed the devices could not assemble together.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
There is no update to the prior event description provided.

• Brand Name: 50MM O.D. SIZE HH POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH HH LINERS
• Common Device Name: PROSTHETIC, 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: 18064656
• Report Number: 0001822565-2023-03045
• Device Sequence Number: 14956079
• Product Code: LPH
• UDI-Device Identifier: 00889024150157
• UDI-Public: (01)00889024150157(17)321213(10)65714788
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K200823
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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 Model Number: N/A
• Device Catalogue Number: 00875305001
• Device Lot Number: 65714788
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• 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: Unknown
• 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
• Patient Age: 28 YR
• Patient Sex: Male