MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM TRILOGY ALLOFIT LONGEVITY 32MM I.D. SIZE MM ELEVATED RIM LINER; PROTHESIS HIP

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: country: taiwan.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 the hip surgery, when trying to tap the liner into the cup, a seesaw motion occurred.Only the upper or lower section could be inserted.There was nothing unusual about the appearance of the implant.Repeated attempts were made to insert the cup, and there was approximately an 18-minute delay.It was reported that the liner had a very high possibility of defects.A new liner was used and successfully clicked it into the cup slot.There was no reported adverse patient impact.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Product has not been 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
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.The following sections were updated: b4;d9;g3;h2;h3;h6 product was returned and evaluated.Visual examination of the returned product identified indentations to the inner and outer spherical surfaces, locking features, and the rim face from attempted implant.No other damage was noted.The device was measured and found to be within specification.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Unable to perform a compatibility check due to insufficient data provided.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.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 is available at the time of this report.

• Brand Name: CONTINUUM TRILOGY ALLOFIT LONGEVITY 32MM I.D. SIZE MM ELEVATED RIM 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: 20611631
• Report Number: 0001822565-2024-03488
• Device Sequence Number: 7327648
• Product Code: LZO
• UDI-Device Identifier: 00889024149830
• UDI-Public: (01)00889024149830(17)280506(10)65966177
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K093846
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2025

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 Model Number: N/A
• Device Catalogue Number: 00875201432
• Device Lot Number: 65966177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 12/04/2024; 03/25/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/05/2024; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Unknown
• Patient Weight: 107 KG