MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, ø 32/+3.5, TAPER 12/14; 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	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a hip replacement, the patient underwent a revision surgery approximately 4 years post implantation due to dislocation.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
(b)(4).D10.60mm o.D.Size mm porous uncemented with cluster holes shell use with mm liners for export only item# 65875306001 lot# 63834639.32mm i.D.Size mm elevated rim liner use with 60mm o.D.Size mm shell item# 00875201432 lot# 63640358.Snap on spherz item# 000-0112 lot# 18170620.Camera drape item# 000-0212 lot# d182461.Avenirâ® mã¼ller, stem, standard, uncemented, ha, 6, taper 12/14 item# 0106010006 lot# 2887675.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.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.No product was returned to the post market surveillance team for examination.However, one image was provided showing the explanted components (cup, insert, head) in the operating theater.The insert can be seen still assembled with the cup.The head is separated from the stem.All components are covered in biological debris.There are some metal smearing to be seen within the taper of the head and a big metal smearing on the articulating surface, likely stemming from the revision surgery or from the event of dislocation.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.Based on the available information, the reported event can be confirmed.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.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, ø 32/+3.5, TAPER 12/14
• 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: 20239026
• Report Number: 0009613350-2024-00456
• Device Sequence Number: 15494715
• Product Code: LZO
• UDI-Device Identifier: 00889024430334
• UDI-Public: (01)00889024430334(17)291231(10)3015945
• 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: 2020
• 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): 11/01/2024

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: 00877503203
• Device Lot Number: 3015945
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male