MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM; PROSTHESIS, HIP

Catalog Number	00875201832
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ china.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is implanted.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, it was difficult to implant the liner into the cup, which led to poor stability of the cup.The cup remained loose.A new cup was implanted and the same liner was able to be used.There was a five-minute delay.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; e1; g3; h2; h3; h4; h6; h10 visual examination of the returned product identified that the shell shows discoloration and damage to the tm outer surface.Rim face, anti rotation scallops, taper wall, and inner spherical surfaces show damage from attempted use and removal.Foreign or bio debris is present.Overall diameter was measured and is within specification.The liner was not returned for review and remains implanted.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.The root cause of the reported issue is attributed to the use of incompatible sizing of implants; size pp shell was used with size qu liner.Zimmer biomet has not confirmed the compatibility for these combinations of devices."improper selection, placement, positioning, alignment and fixation of the implant components, or absence of, or non-functioning quadriceps mechanism may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." and "zimmer biomet or its affiliates are not liable for complications and/or failure that may arise from use of the device in circumstances outside of zimmer biomet¿s or its affiliates control including, but not limited to, product selection and deviations from the device¿s indicated uses or surgical technique." 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
No further information is available at the time of this report.

• Brand Name: CONTINUUM
• 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: 22527229
• Report Number: 0001822565-2025-02567
• Device Sequence Number: 15803306
• Product Code: JDI
• UDI-Device Identifier: 00889024149953
• UDI-Public: (01)00889024149953(17)290108(10)66420509
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2025

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 Catalogue Number: 00875201832
• Device Lot Number: 66420509
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 12/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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 Sex: Unknown