MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HEADS PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: report source japan.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 Description

It was reported that a patient underwent a revision approximately 2 years post implantation due to hip dislocation and disassembly during the closed reduction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified metal marks on the articulation surface, which are concentrated in an area near the zenith, which indicates direct contact with a metal component.There are also small, individual metal traces distributed over the entire device.The head taper shows heavy metal marks indicating an inconspicuous seating pattern.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Medical records were not provided.With the available information, the reported dislocation can be confirmed; nevertheless, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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 Description

No further event information available at the time of this report.

• Brand Name: BIOLOX DELTA HEADS PROSTHESIS, HIP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18057404
• MDR Text Key: 327190942
• Report Number: 0009613350-2023-00609
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877502802
• Device Lot Number: 3077095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 28MM I.D. 44MM O.D. SIZE F BEARING.; 28MM I.D. 44MM O.D. SIZE F BEARING.; G7 DUAL MOBILITY LINER 44MM F.; MODULAR NECK DD 12/14 NECK TAPER.; MODULAR NECK DD 12/14 NECK TAPER.
• Patient Outcome(s): Hospitalization; Required Intervention