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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent revision approximately 6 years post implantation due to dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).G2: report source: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Femoral stem 12/14 neck taper ext.Offset size 4 130 mm stem length; item# 00811400410; lot# 63724908 shell porous without holes 58 mm o.D.With calcicoat ceramic coating; item# 65620005821; lot# 63382517 allen medullary cement plugs 1-28 mm diameter flange/14 mm diameter core store in cool dry place; item# 00801102028; lot# 63862008 liner 10 degree elevated rim 3.5 mm offset 36 mm i.D.For use with 58 mm o.D.Shell; item# 00631005836; lot#63417809 no product was returned for evaluation.Visual examination of the provided picture shows the explanted devices.The ceramic head is still on the stem.The parts are still in a bloody condition.No further statement can be made based on the provided picture.Review of the device history records for the ceramic head identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for this item and the reported part and lot combination.With the available information, a definitive root cause could not 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOLOX DELTA HEADS
• Common Device Name: 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: 18827428
• Report Number: 0009613350-2024-00079
• Device Sequence Number: 16886643
• Product Code: LZO
• UDI-Device Identifier: 00889024430389
• UDI-Public: (01)00889024430389(17)270430(10)2890293
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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): 06/07/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877503604
• Device Lot Number: 2890293
• Was Device Available for Evaluation?: No
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALLEN MEDULLARY CEMENT PLUGS 1-28 MM; FEMORAL STEM 12/14 NECK TAPER SIZE 4 130 MM; LINER 10 DEGREE ELEVATED RIM 3.5 MM; SEE H11; SHELL POROUS WITHOUT HOLES 58 MM
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male