MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LONGEVITY 36MM I.D. SIZE E HIGH WALL LINER; PROTHESIS, 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	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cat# unknown lot# unknown cup.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 during right hip surgery, the liner would not engage with the cup.The liner went in and was flush but would pop out as soon as the hip was relocated and put through a range of motion.Three attempts were made with the same result.The liner was replaced with a new one and worked properly.It was also reported that surgical technique was utilized.There was no patient impact, no surgical delay, and no surgical complications.The patient's anatomy did not contribute to the event.No additional information available.
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 and corrected information.A visual examination of the returned product identified indentations on the high sidewall, sidewall, and inner spherical surface from attempted use.No other damage was noted.Medical records were not provided.Product identifiers from the print were inspected and were found to be conforming.A review of the device history records identified no deviations or anomalies during manufacturing.Insufficient information was provided; therefore, a compatibility check could not be performed.The reported issue was confirmed based on the damage from attempted use.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: LONGEVITY 36MM I.D. SIZE E HIGH WALL LINER
• 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: 18491104
• Report Number: 0001822565-2024-00141
• Device Sequence Number: 7188371
• Product Code: LPH
• UDI-Device Identifier: 00889024519329
• UDI-Public: (01)00889024519329(17)280828(10)66199100+
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/21/2024

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: 20123605
• Device Lot Number: 66199100
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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