MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 52MM O.D. SIZE II POROUS UNCEMENTED WITH MULTI-HOLES SHELL; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cat# 00-8751-010-36 lot# 65377036 continuum longevity neutral liner, ii 36 x 52; cat# 00-6250-065-30 lot # j7593913 bone screw 6.5x30 selftap; cat# 574101030 lot# 3121808 avenir cmpl ha std nc size 3; cat# 00-8775-036-01 lot# 3171528 biolox delta fem head, 36mm, -3.5mm; cat# 00626001800 lot# 62641799 cup positioner.Multiple mdr reports were filed for this event, please see associated report: 0001822565-2024-00042.Customer has indicated that the product was implanted and will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during surgery, the cup inserter was screwed into the cup but would not release or unscrew from the cup.The cup got stuck in the femur and had to be pried off the inserter with a curette and pliers.The cup was removed from the inserter.There was no damage noted to the cup, so it was implanted.The inserter needed to be replaced.It was reported that surgical technique was utilized.There was no patient impact or injury.There were also no surgical complications, and no foreign body retained.No additional information.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned; however, pictures were provided and reviewed.An examination of the provided pictures identified that the cup positioner was covered in bio-debris and detached from the shell.The pictures did not capture the threads enough for further review.Pictures were not provided of the shell.No further evaluation can be made.Medical records were not provided.A review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.The reported issue cannot be confirmed, and 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.

• Brand Name: 52MM O.D. SIZE II POROUS UNCEMENTED WITH MULTI-HOLES SHELL
• Common Device Name: PROTHESIS, 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: 18467229
• Report Number: 0001822565-2024-00044
• Device Sequence Number: 12532538
• Product Code: LPH
• UDI-Device Identifier: 00889024151383
• UDI-Public: (01)00889024151383(17)330812(10)66138015
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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: 00875705202
• Device Lot Number: 66138015
• 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: 12/29/2023
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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
• 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 Sex: Female