MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM TRILOGY ALLOFIT LONGEVITY 28MM I.D. SIZE FF ELEVATED RIM LINER; PROSTHESIS, 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	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cat# 00875304601 lot# 65860371 46mm o.D.Size ff porous uncemented with cluster holes shell use with ff liners.G2: foreign: china.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 during the surgery the liner would not assemble to the cup.A new liner was used to successfully complete the procedure.There was no known impact or consequences to the patient.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.Visual examination of the provided pictures and returned product identified liner shows gouges and indentations to the rim, inner spherical surface, and elevated anti rotation scallops.Cut outs on the outer spherical surface show indentations and deformation from attempted implanting.Product identifier for cutout diameter was measured and found to be in specification.Device was 100% cmm inspected during manufacturing.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.Based on the product review, the complaint is 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
There is no update to the prior event description provided.

• Brand Name: CONTINUUM TRILOGY ALLOFIT LONGEVITY 28MM I.D. SIZE FF ELEVATED RIM LINER
• 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: 20006004
• Report Number: 0001822565-2024-02683
• Device Sequence Number: 17233946
• Product Code: JDI
• UDI-Device Identifier: 00889024149656
• UDI-Public: (01)00889024149656(17)270624(10)65533954
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/05/2024

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: 00875200728
• Device Lot Number: 65533954
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Age: 68 YR
• Patient Sex: Female